TIGER BALM  NECK AND SHOULDER RUB- camphor (synthetic) and menthol, unspecified form cream 
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.

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TIGER BALM®
NECK &
SHOULDER
RUB

Drug Facts

Active Ingredients

Camphor 11%, Menthol 10%

Purpose

Topical analgesics

Uses

For temporary relief of minor aches and pains of neck and shoulder muscles and joints

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 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.

Directions

Other information

This product may cause allergic reaction in some individuals. Test on small area before use.

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.

Manufactured for Haw Par Healthcare Ltd., Singapore under licence from Haw Par Corporation Ltd.

Questions/Comments

(510) 887-1899

PRINCIPAL DISPLAY PANEL - 50g Carton

NDC 66761-341-50

TIGER BALM®

TIGER BALM®
NECK &
SHOULDER
RUB

Pain Relieving
Cream

Non-Greasy

Fast Relief

VANISHING
SCENT

Fast relief for stressed
and strained muscles

Net Wt. 1.76 oz (50g)

Principal Display Panel - 50g Carton
TIGER BALM   NECK AND SHOULDER RUB
camphor (synthetic) and menthol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66761-341
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 11 mg  in 1 g
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Eucalyptus oil (UNII: 2R04ONI662)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Glycerin (UNII: PDC6A3C0OX)  
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Trolamine (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
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; Type 0: Not a Combination Product
2 NDC:66761-341-01 1 in 1 CARTON
2 5 g in 1 TUBE; Type 0: Not a Combination Product
3 NDC:66761-341-03 3 g 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 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)

Revised: 1/2015
Document Id: 95b14dd1-0280-4548-adc8-951939e67d88
Set id: 2f272d12-7b34-430e-817e-1005f57ed9e9
Version: 3
Effective Time: 20150109
 
Haw Par Healthcare Ltd.