Tiger Balm Spray
FDA Label NDC 66761-327

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 (NDC 66761-327). 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, flammable, 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 OLIC (Thailand) Limited for Haw Par Healthcare Ltd., Singapore under licence from Haw Par Corporation Ltd.

Otc - Purpose

Active Ingredients (w/w)Purpose
Methyl Salicylate 25%Topical Analgesic
Menthol 16%Topical Analgesic
Camphor 7%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 within 30 minutes after bathing
  • Avoid inhalation
  • Do not use in confined space.

Flammable

  • Do not use near heat or flame or while smoking
  • Avoid long term storage above 104°F (40°C)
  • Do not puncture or incinerate. Contents under pressure
  • Do not store at temperatures above 120°F (49°C).

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 years of age, spray on the affected area. Repeat 3 to 4 times daily
  • For children 12 years of age or younger, consult a doctor before use
  • Shake well before use. Point spray towards area to be treated. Spray in short bursts about 6 inches from the skin. The product is quickly absorbed, but may be rubbed in after spraying if desired.

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
  • Store at room temperature.

Inactive Ingredients

Ethanol (Dehydrated Alcohol), Liquefied Petroleum Gas.

Questions

(925) 292-3888

Principal Display Panel - 75 Ml Canister Carton

TIGER BALM®

NDC 66761-327-75

ACTIVE

Pain Relieving
MUSCLE
SPRAY

  • EASY-TO-APPLY
  • FOR HARD TO REACH
    AREAS

    • NET 2.53 Fl. Oz. (75ml)

    Principal Display Panel (75 ml Canister Carton)

    Principal Display Panel (75 ml Canister Carton)

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