Label: TIGER BALM ACTIVE MUSCLE RUB (methyl salicylate, menthol, unspecified form, and camphor- synthetic cream
- NDC Code(s): 66761-129-02, 66761-129-60
- Packager: Haw Par Healthcare Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 26, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
TIGER BALM ACTIVE MUSCLE RUB
methyl salicylate, menthol, unspecified form, and camphor (synthetic) cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66761-129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 150 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 50 mg in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 30 mg in 1 g Inactive Ingredients Ingredient Name Strength DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66761-129-60 1 in 1 BOX 05/01/2018 1 60 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:66761-129-02 2 g in 1 POUCH; Type 0: Not a Combination Product 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 05/01/2018 Labeler - Haw Par Healthcare Ltd. (659207039)