Label: TIGER BALM (camphor- synthetic, menthol, and capsicum patch
- NDC Code(s): 66761-322-01, 66761-322-02, 66761-322-05, 66761-322-12
- Packager: Haw Par Healthcare Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 8, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
FOR EXTERNAL USE ONLY
When using this product
- Use only as directed
- Do not get into eyes or on mucous membranes
- Do not apply to wounds, damaged or irritated skin
- Do not bandage or cover with any type of wrap except clothing
- Do not use with a heating pad or apply external heat
- 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
- Symptoms clear up and occur again within a few days
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Directions
- Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
- Children under 12 years, consult doctor before use
- How to apply:
- Clean and dry affected area
- Cut open pouch and remove patch
- Remove protective film and apply directly to area of pain
- Apply to affected area not more than 3 times daily
- Wash hands with soap after applying patch
- Other Information
- Inactive Ingredients
- Questions/Comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 Patch Packet
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INGREDIENTS AND APPEARANCE
TIGER BALM
camphor (synthetic), menthol, and capsicum patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66761-322 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 80 mg Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form 24 mg Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 16 mg Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) Eucalyptus Oil (UNII: 2R04ONI662) Glycerin (UNII: PDC6A3C0OX) Hydrotalcite (UNII: 17432CG1KU) Kaolin (UNII: 24H4NWX5CO) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) Polysorbate 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66761-322-01 36 in 1 BOX 11/15/2001 1 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:66761-322-05 1 in 1 BOX 11/15/2001 2 5 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:66761-322-02 36 in 1 BOX 11/15/2001 3 1 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:66761-322-12 12 in 1 BOX 12/01/2016 4 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M017 11/15/2001 Labeler - Haw Par Healthcare Ltd. (659207039) Establishment Name Address ID/FEI Business Operations Haw Par Healthcare Ltd. 659207039 MANUFACTURE(66761-322) Establishment Name Address ID/FEI Business Operations Tiger Balm (Malaysia) Sdn. Bhd. 813058014 MANUFACTURE(66761-322)