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Drug Facts
Healthwise Ultra Otc Strength Pain Relief Cream
FDA Label NDC 71101-070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Ultra Otc Strength Pain Relief Cream (NDC 71101-070). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, use, warnings, do not use, stop use and ask a physician if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Methyl Salicylate 30%
Menthol 10%
Camphor 4%
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Camphor 4% | Topical analgesic |
| Menthol 10% | Topical analgesic |
| Methyl salicylate 30% | Topical analgesic |
Use
For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
Warnings
For external use only.
Do Not Use
- than otherwise directed
- on wounds or damaged skin
- a bandage tightly
Stop Use And Ask A Physician If
- rash or excessive irritation of the skin develops
- condition worsens or symptoms persist for more than 7 days
- condition clears up and occurs again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
Directions
Adults and children 2 years of age and older:
- apply to affected area no more than 3 to 4 times daily
- do not use, ask a doctor
Children under 2 years of age:
Other Information
- store at 20°C -25°C(68 to 77°F)
Inactive Ingredients
Inactive ingredients
carbomer, disodium EDTA, glyceryl stearate, lanolin, polysorbate 80, potassium hydroxide, stearic acid, water
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