Label: TIGER BALM NECK AND SHOULDER RUB- camphor (synthetic) and menthol, unspecified form cream
- NDC Code(s): 66761-341-01, 66761-341-03, 66761-341-50
- 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 Ingredients
Camphor 11%, Menthol 10%Close
For temporary relief of minor aches and pains of neck and shoulder muscles and jointsClose
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 breastfeeding, 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.
- For adults and children over 12 years, 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.
- Other information
This product may cause allergic reaction in some individuals. Test on small area before use.Close
- Inactive Ingredients
Dementholised Mint Oil, Diazolidinyl Urea, Eucalyptus Oil, FD&C Blue 1, Glycerin, Lavender Fragrance, Methyl Glucose Dioleate, Methylparaben, PVM/MA Decadiene Crosspolymer, Propylene Glycol, Propylparaben, Triethanolamine (TEA), Water.Close
- SPL UNCLASSIFIED SECTION
Manufactured for Haw Par Healthcare Ltd., Singapore under licence from Haw Par Corporation Ltd.Close
- PRINCIPAL DISPLAY PANEL - 50g Carton
Fast relief for stressed
and strained muscles
Net Wt. 1.76 oz (50g)
- INGREDIENTS AND APPEARANCE
TIGER BALM NECK AND SHOULDER RUB
camphor (synthetic) and menthol cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66761-341 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Camphor (Synthetic) (Camphor (Synthetic)) Camphor (Synthetic) 11 mg in 1 g Menthol, Unspecified Form (Menthol, Unspecified Form) Menthol, Unspecified Form 10 mg in 1 g Inactive Ingredients Ingredient Name Strength Diazolidinyl Urea Eucalyptus oil FD&C Blue No. 1 Glycerin Peg-120 Methyl Glucose Dioleate Methylparaben Propylene Glycol Propylparaben Trolamine Water Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66761-341-50 1 in 1 CARTON 1 50 g in 1 TUBE; Combination Product Type = C112160 2 NDC:66761-341-01 1 in 1 CARTON 2 5 g in 1 TUBE; Combination Product Type = C112160 3 NDC:66761-341-03 3 g in 1 PACKET; Combination Product Type = C112160 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 10/24/2008 Labeler - Haw Par Healthcare Ltd. (659207039) Establishment Name Address ID/FEI Business Operations Drug Houses of Austrailia Asia PTE LTD 595132739 MANUFACTURE(66761-341) Establishment Name Address ID/FEI Business Operations OLIC (Thailand) Limited 659673016 MANUFACTURE(66761-341)