TIGER BALM- methyl salicylate and menthol liniment Haw Par Healthcare Ltd. 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. ------TIGER BALM® LINIMENT Drug Facts
Active Ingredients Purpose Methyl Salicylate 28% Topical Analgesic Menthol 16% Topical Analgesic
Uses For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, sprains and strains.
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.
Directions 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
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.
Inactive Ingredients Eucalyptus Oil, Spike Lavender Oil, Light Mineral Oil.
Questions (925) 292-3888 Manufactured by Haw Par Healthcare Ltd., Singapore under licence from Haw Par Corporation Ltd.
PRINCIPAL DISPLAY PANEL - 57 ml Bottle Box NDC 66761-333-22 TIGER BALM® LINIMENT PAIN RELIEVING LINIMENT NON-STAINING 2 FL.OZ. 57ml
TIGER BALM methyl salicylate and menthol liniment
Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 6 76 1-333 Route of Administration TOPICAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 26 0 .4 mg Methyl Sa licyla te (UNII: LAV5U50 22Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate in 1 mL Mentho l, Unspecified Fo rm (UNII: L7T10 EIP3A) (Mentho l, Unspecified Fo rm - Mentho l, Unspecified 148 .8 mg UNII:L7T10 EIP3A) Fo rm in 1 mL
Inactive Ingredients Ingredient Name Strength Euca lyptus o il (UNII: 2R0 4ONI6 6 2) spike la vender o il (UNII: 7S2HYV1VJQ) lig ht minera l o il (UNII: N6 K578 7QVP)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:6 6 76 1-333-22 1 in 1 BOX 12/0 8 /20 0 5 1 57 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC MONOGRAPH NOT FINAL part348 12/0 8 /20 0 5
Labeler - Haw Par Healthcare Ltd. (659207039)
Establishment Name Addre ss ID/FEI Busine ss Ope rations Haw Par Healthcare Ltd. 6 59 20 70 39 MANUFACTURE(6 6 76 1-333)
Revised: 2/2018 Haw Par Healthcare Ltd.