Label: TIGER BALM- methyl salicylate and menthol liniment
- NDC Code(s): 66761-333-22
- Packager: Haw Par Healthcare Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, sprains and strains.Close
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 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 childern. If swallowed, get medical help or contact a Poison Control Center immediately.
- For adults and children over 12, rub well on the affected area. Repeat 3-4 times daily
- For children 12 years of age or younger, consult a doctor before use
- Other Information
This product may cause allergic reaction in some individuals. Test on small area before use.Close
- Inactive Ingredients
Eucalyptus Oil, Spike Lavender Oil, Light Mineral Oil.Close
- PRINCIPAL DISPLAY PANEL - 57ml Carton
2 FL.OZ. 57ml
- INGREDIENTS AND APPEARANCE
methyl salicylate and menthol liniment
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66761-333 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Methyl Salicylate (Salicylic Acid) Methyl Salicylate 260.4 mg in 1 mL Menthol (Menthol) Menthol 148.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength Eucalyptus oil spike lavender oil light mineral oil Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66761-333-22 1 in 1 BOX 1 57 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 12/08/2005 Labeler - Haw Par Healthcare Ltd. (659207039) Registrant - Tiger Balm (Malaysia) Sdn. Bhd. (652104126) Establishment Name Address ID/FEI Business Operations Haw Par Healthcare Ltd. 659207039 MANUFACTURE(66761-333)