Tiger Balm Red Ointment
FDA Label NDC 66761-308

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haw Par Healthcare Ltd. for the product Tiger Balm Red (NDC 66761-308). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, when using this product, otc - do not use, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active IngredientsPurpose
Camphor 11%Topical Analgesic
Menthol 10%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

Otc - Do Not Use

  • 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

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

  • This product may cause allergic reaction in some individuals. Test on small area before use
  • Tiger Balm Red Extra Strength may stain cloth items. To avoid possibility of strains, use Tiger Balm White Regular Strength or Tiger Balm Ultra Strength.

Inactive Ingredients

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

Questions

(510) 887-1899

Principal Display Panel - 18 G Jar Box

NDC 66761-308-25

TIGER BALM®

RED EXTRA STRENGTH

PAIN RELIEVING OINTMENT

NET WT: 0.63 OZ (18G)

Principal Display Panel (18 g Jar Box)

Principal Display Panel (18 g Jar Box)

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