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Drug Facts
Tiger Balm Cream
FDA Label NDC 66761-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haw Par Healthcare Ltd. for the product Tiger Balm (NDC 66761-129). 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 - purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients | Purpose |
|---|---|
| Methyl Salicylate 15% | Topical Analgesic |
| Menthol 5% | Topical Analgesic |
| Camphor 3% | Topical Analgesic |
Uses
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains.
Warnings
For external use only.
When Using This Product
- Use only as directed
- Avoid contact with eyes and mucous membranes
- Do not apply to wounds, damaged or irritated skin
- Do not bandage or cover with wrap or use heating pad
- Do not use 1 hour prior to bathing or within 30 minutes after bathing.
Stop Use And Ask A Doctor If
- Condition worsens
- Severe skin irritation occurs
- Pain persists for more than 7 days
- Pain clears up and then recurs a few days later.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare 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 immediately.
Directions
- For adults and children over 12 years of age, rub well on the affected area. Repeat 3 to 4 times daily
- For children 12 years of age or younger, consult a doctor before use.
Other Information
- Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use
- This product may cause allergic reaction on some individuals. Test on small area before use
- Store at room temperature.
Inactive Ingredients
Diazolidinyl Urea, Glycerin, Methyl Glucose Dioleate, Methyl Paraben, Poly (Methyl Vinyl Ether/Maleic Anhydride) Decadiene Crosspolymer, Propyl Paraben, Propylene Glycol, Purified Water, Triethanolamine.
Questions
(925) 292-3888
Principal Display Panel
TIGER BALM®
NDC 66761-129-60
ACTIVE
MUSCLE
RUB
- PRE-SPORTS WARM-UP
- RELIEF FOR SORE MUSCLES
- NON-GREASY PAIN RELIEF
CREAM
NET WT. 2 OZ. (60G)
Principal Display Panel (60 G Tube Box)
TIGER BALM®
ACTIVE
MUSCLE RUB
NET WT. 0.07 OZ. (2G)
Sample
Not For Sale
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