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| Product NDC Code | 71101-040 | ||||
|---|---|---|---|---|---|
| Drug Name | Healthwise menthol 4% roll-on |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M017 | ||||
| Labeler Name | Veridian Healthcare | ||||
| 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 4%
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 no more than 3 to 4 times daily ■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH 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 acrylates/C10-30 alkyl acrylate crosspolymer (6000 MPA.S), capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol, triethanolamine, water Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethyl propanol, ceteth-10 phosphate, cetostearyl alcohol, Cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 MPA.S at 1.5%), isohexadecane, phenoxyethanol, SD alcohol, steareth-21, water
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 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
Spl product data elements
Usually a list of ingredients in a drug product.HealthWise Menthol 4% Roll-On Menthol GLYCERIN ALOE VERA LEAF CARBOMER 940 CAMPHOR (NATURAL) TROLAMINE ALCOHOL ARNICA MONTANA FLOWER WATER MENTHOL MENTHOL ISOPROPYL MYRISTATE CALENDULA OFFICINALIS FLOWER .ALPHA.-TOCOPHEROL ACETATE MELISSA OFFICINALIS LEAF ARCTIUM LAPPA WHOLE GREEN TEA LEAF ILEX PARAGUARIENSIS LEAF INDIAN FRANKINCENSE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER FD&C YELLOW NO. 5 FD&C BLUE NO. 1
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 Pack
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.HealthWise Menthol 4% Roll-On
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 (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments Call 1-866-326-1313
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 you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied Flammable ■ Keep away from fire or flame
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 When using this product ■ use only as directed. Read and follow all directions and warnings on this carton ■ rare cases of serious burns have been reported with products of this type ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ avoid contact with eyes and mucous membranes ■ do not apply to wounds or damaged, broken or irritated skin ■ 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 the 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 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 When using this product When using this product ■ use only as directed. Read and follow all directions and warnings on this carton ■ rare cases of serious burns have been reported with products of this type ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use ■ avoid contact with eyes and mucous membranes ■ do not apply to wounds or damaged, broken or irritated skin ■ 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 the 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 Flammable ■ Keep away from fire or flame 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 (1-800-222-1222) 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