Tiger Balm
Tiger Balm Active Muscle Gel
845a4ead-f9c0-4009-bcae-b17cd388439b
HUMAN OTC DRUG LABEL
May 28, 2025
Haw Par Healthcare Ltd.
DUNS: 659207039
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methyl Salicylate and Menthol, Unspecified Form
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 60 G Tube Box
TIGER BALM®
NDC 66761-128-60
ACTIVE
MUSCLE
GEL
- COOLING RELIEF
- MILDLY-SCENTED
- NON-STICKY PAIN RELIEF GEL
NET WT. 2 OZ. (60G)
INDICATIONS & USAGE SECTION
Uses
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains.
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
|
Active Ingredients |
Purpose |
|---|---|
|
Methyl Salicylate 16% |
Topical Analgesic |
|
Menthol 8% |
Topical Analgesic |
WARNINGS SECTION
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.
If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
DOSAGE & ADMINISTRATION SECTION
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.
STORAGE AND HANDLING SECTION
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 INGREDIENT SECTION
Inactive Ingredients
Carbomer 940, Citric Acid Monohydrate, FD&C Blue No. 1, Fragrance Active Fresh 1, Methylated Spirit, PEG-15 Cocamine, PPG-5 Ceteth-20, Propylene Glycol, Purified Water.
OTC - QUESTIONS SECTION
Questions
(925) 292-3888