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| Product NDC Code | 57598-888 | ||||||||
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| Drug Name | Ultra balm |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OINTMENT | ||||||||
| RxCUI drug identifier | 1433200, 1433205 |
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| Application Number | M017 | ||||||||
| Labeler Name | Ling Nam Medicine Factory (H.K.) Ltd. | ||||||||
| 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 Ingredients Purpose Menthol 14% Topical analgesic Methyl Salicylate 23.2% Topical analgesic
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 for adults and children 12 years of age and over, apply to affected area not more than 3 to 4 times daily for children 12 years or younger, consult a doctor before use not intended for children under two years of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Eucalyptus Oil, Lanolin, Paraffin, Petroleum Jelly and Thyme Oil
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 for temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Active Ingredients Purpose Menthol 14% Topical analgesic Methyl Salicylate 23.2% Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Ultra Balm Menthol and Methyl Salicylate Menthol, Unspecified Form Menthol, Unspecified Form Methyl Salicylate SALICYLIC ACID Eucalyptus Oil Lanolin Paraffin Petrolatum Thyme Oil
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 - 19.8 g Jar Carton NDC.No : 57598-888-07 ULTRA BALM LING NAM ® EXTERNAL ANALGESIC COOLING PAIN RELIEF Ling Nam Medicine Factory (H.K.) Limited Tuen Mun, New Territories, Hong Kong, China U.S.A. Sole Distributor: TCM Herbalway Inc. Covina, CA 91724 U.S.A. www.tcmherbalway.com Made in China Hong Kong Net Wt.0.7 oz (19.8g) PRINCIPAL DISPLAY PANEL - 19.8 g Jar Carton
PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton NDC.No : 57598-888-23 ULTRA BALM LING NAM ® EXTERNAL ANALGESIC COOLING PAIN RELIEF Ling Nam Medicine Factory (H.K.) Limited Tuen Mun, New Territories, Hong Kong, China Made in China Net Wt.2.3 oz (65.1g) PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton
PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton - NDC 57598-888-88 NDC.No : 57598-888-88 ULTRA BALM LING NAM ® EXTERNAL ANALGESIC COOLING PAIN RELIEF Ling Nam Medicine Factory (H.K.) Limited Tuen Mun, New Territories, Hong Kong, China U.S.A. Sole Distributor: TCM Herbalway Inc. Covina, CA 91724 U.S.A. www.tcmherbalway.com Made in China Hong Kong Net Wt.2.3 oz (65.1g) PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton - NDC 57598-888-88
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.Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use If prone to allergic reaction from aspirin or salicylates
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 to avoid accidental poisoning. If swallowed, get medical help or contact Poison Control Center right away. Do not use otherwise than as directed.
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? Please call 1-888-915-6789.
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 skin irritation or redness develops pain persists for more than 7 days clear up and occur again within a few days
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 avoid contact with eyes or mucous membranes do not apply to wounds, damaged or irritated skin do not bandage tightly or use with heating pad do not use 1 hour prior to bathing or 30 minutes after bathing
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Close cap tightly after use. Store in cool place.
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 Do not use If prone to allergic reaction from aspirin or salicylates When using this product avoid contact with eyes or mucous membranes do not apply to wounds, damaged or irritated skin do not bandage tightly or use with heating pad do not use 1 hour prior to bathing or 30 minutes after bathing Stop use and ask a doctor if condition worsens skin irritation or redness develops pain persists for more than 7 days clear up and occur again within a few days If pregnant or breastfeeding, ask health professional before use. Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact Poison Control Center right away. Do not use otherwise than as directed.
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