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| Product NDC Code | 41167-0087 | ||||
|---|---|---|---|---|---|
| Drug Name | Icy hot pain relieving balm |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 311500, 311510, 1044268 |
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| Application Number | M017 | ||||
| Labeler Name | Chattem, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 10% Methyl salicylate 30%
Active ingredient Menthol 7.6% Methyl salicylate 29%
Active ingredient Menthol 10% Methyl salicylate 30%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children over 12 years: apply a thin layer to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but not more than 4 times daily children 12 years or younger: ask a doctor
Directions adults and children over 12 years: ■ apply a thin layer to affected area ■ massage into painful area until thoroughly absorbed into skin ■ repeat as necessary, but no more than 4 times daily ■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER children 12 years or younger: ask a doctor
Directions adults and children over 12 years: ■ apply a thin layer to affected area ■ massage into painful area until thoroughly absorbed into skin ■ repeat as necessary, but no more than 4 times daily ■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER children 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111) ICYHOT ® PAIN RELIEVING BALM Drug Facts
Inactive ingredients paraffin, white petrolatum ICYHOT ® PAIN RELIEVING CREAM Drug Facts
Inactive ingredients carbomer, cetearyl alcohol, cetyl esters, oleth-3 phosphate, polysorbate 60, stearic acid, triethanolamine, water Close cap tightly after use.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps
Uses temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps
Uses temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Purpose Topical analgesic
Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Icy Hot Pain Relieving Stick Menthol and Methyl Salicylate MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID CERESIN CYCLOMETHICONE HYDROGENATED CASTOR OIL MICROCRYSTALLINE WAX PARAFFIN PEG-150 DISTEARATE PROPYLENE GLYCOL STEARIC ACID STEARYL ALCOHOL Icy Hot Pain Relieving Balm Menthol and Methyl Salicylate MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID PARAFFIN PETROLATUM Icy Hot Pain Relieving Cream Menthol and Methyl Salicylate MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID CETYL ESTERS WAX OLETH-3 PHOSPHATE STEARIC ACID WATER TROLAMINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL ICYHOT ® PAIN RELIEVING STICK EXTRA STRENGTH PAIN RELIEVING STICK Net wt 1. 7 5 oz ( 49 g) PRINCIPAL DISPLAY PANEL ICYHOT® PAIN RELIEVING STICK EXTRA STRENGTH Net wt 1.75 oz (49 g)
PRINCIPAL DISPLAY PANEL ICY HOT ® ORIGINAL PAIN RELI EF BALM N ET WT 3.5 OZ (99.2 g) ICY HOT® ORIGINAL PAIN RELIEF BALM NET WT 3.5 OZ (99.2 g) ICY HOT ORIGINAL PAIN RELIEF BALM
PRINCIPAL DISPLAY PANEL ICYHOT ® PAIN RELIEVING CREAM Net wt 1. 25 oz ( 35.4 g) PRINCIPAL DISPLAY PANEL ICYHOT® PAIN RELIEVING CREAM Net wt 1.25 oz (35.4 g) EXTRA STRENGTH
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.ICYHOT ® PAIN RELIEVING STICK Drug Facts
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days
Stop use and ask a doctor if ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Stop use and ask a doctor if ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight
When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ do not use at the same time as other topical analgesics ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight ■ avoid applying into skin folds
When using this product ■ use only as directed. Read and follow all directions and warnings on this carton. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ do not use at the same time as other topical analgesics ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight ■ avoid applying into skin folds
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care professional before use.
If pregnant or breast- feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only SEE INSIDE LABEL FOR COMPLETE DRUG FACTS Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use When using this product ■ use only as directed. Read and follow all directions and warnings on this label. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ do not use at the same time as other topical analgesics ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight ■ avoid applying into skin folds Stop use and ask a doctor if ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use When using this product ■ use only as directed. Read and follow all directions and warnings on this carton. ■ avoid contact with eyes and mucous membranes ■ rare cases of serious burns have been reported with products of this type ■ do not apply to wounds or damaged, broken or irritated skin ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ do not use at the same time as other topical analgesics ■ a transient burning sensation may occur upon application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not expose the area treated with product to heat or direct sunlight ■ avoid applying into skin folds Stop use and ask a doctor if ■ condition worsens ■ redness is present ■ irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API