TIGER BALM  ULTRA STRENGTH- camphor (synthetic) and menthol ointment 
Tiger Balm (Malaysia) Sdn. Bhd.

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®
Ultra STRENGTH

Drug Facts

Active IngredientsPurpose
Camphor 11%Topical Analgesic
Menthol 11%Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains.

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 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 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.

Inactive Ingredients

Cajuput Oil, Cassia Oil, Clove Oil, Dementholised Mint Oil and Paraffin Petrolatum.

Questions/Comments

(510) 887-1899

PRINCIPAL DISPLAY PANEL - 18 g Carton

NDC 66403-315-35

TIGER BALM®

Ultra STRENGTH

"WORKS WHERE IT HURTS"

PAIN RELIEVING OINTMENT

SPORTS RUB

Principal Display Panel - 18 g Carton
TIGER BALM   ULTRA STRENGTH
camphor (synthetic) and menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66403-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)110 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM110 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Cajuput oil (UNII: J3TO6BUQ37)  
Chinese Cinnamon Oil (UNII: A4WO0626T5)  
Clove oil (UNII: 578389D6D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66403-315-351 in 1 BOX01/25/200212/31/2019
118 g in 1 JAR; Type 0: Not a Combination Product
2NDC:66403-315-501 in 1 BOX01/25/200212/31/2019
250 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/25/200212/31/2019
Labeler - Tiger Balm (Malaysia) Sdn. Bhd. (652104126)
Establishment
NameAddressID/FEIBusiness Operations
Tiger Balm (Malaysia) Sdn. Bhd.652104126MANUFACTURE(66403-315)

Revised: 12/2018
Document Id: 3302831b-d9a5-4051-978b-0786cebd9b2c
Set id: 1dfc4535-3b8d-455c-ae10-4c89773ad63e
Version: 3
Effective Time: 20181220
 
Tiger Balm (Malaysia) Sdn. Bhd.