Tiger Balm®

Tiger Balm®
SPL v1
SPL
SPL Set ID 41590ba1-32bb-4352-97ba-d6a3cc9d0546
Route
TOPICAL
Published
Effective Date 2024-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (80 mg) Menthol, Unspecified Form (24 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Castor Oil Dihydroxyaluminum Aminoacetate Edetate Disodium Eucalyptus Oil Glycerin Kaolin Mentha Arvensis Leaf Oil Water Polysorbate 80 Polyvinyl Alcohol, Unspecified Sorbitol Solution Tartaric Acid Urea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

For temporary relief of pains.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Section 53414-9

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

Section 55105-1
Active Ingredients Purpose
Camphor 80mg / patch Topical Analgesic
Menthol 24mg / patch Topical Analgesic
Warnings

FOR EXTERNAL USE ONLY

Directions
  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches
Other Information

This product may cause allergic reaction on some individuals. Store in cool dry place away from direct sunlight.

Questions/comments

(925) 292-3888

Inactive Ingredients

Carboxymethylcellulose Sodium, Castor Oil, Dihydroxyaluminum Aminoacetate, Disodium Edetate, Eucalyptus Oil, Glycerin, Heavy Kaolin, Mentha Oil, Polyacrylic Acid, Purified Water. Polysorbate 80, Polyvinyl Alcohol, Sorbitol Solution, Sodium Polyacrylate, Tartaric Acid, Urea.

When Using This Product
  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use 1 hour prior to bathing or within 30 minutes after bathing
Stop Use and Ask A Doctor If
  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days, or redness is present
  • Symptoms clear up and occur again within a few days
Principal Display Panel 5 Patch Packet

NDC 66761-325-05

TIGER BALM®

TIGER BALM®

PAIN RELIEVING

COOL PATCH

Advanced Hydrogel Patch Technology

Fast Acting Cooling Effect

For temporary relief of pains

  • Works Where it Hurts
  • Long Lasting
  • Easy to Apply and Remove
  • Convenient

5 PATCHES (4 x 2.75 inches each)


Structured Label Content

Uses

For temporary relief of pains.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active Ingredients Purpose
Camphor 80mg / patch Topical Analgesic
Menthol 24mg / patch Topical Analgesic
Warnings

FOR EXTERNAL USE ONLY

Directions
  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches
Other Information

This product may cause allergic reaction on some individuals. Store in cool dry place away from direct sunlight.

Questions/comments (Questions/Comments)

(925) 292-3888

Inactive Ingredients

Carboxymethylcellulose Sodium, Castor Oil, Dihydroxyaluminum Aminoacetate, Disodium Edetate, Eucalyptus Oil, Glycerin, Heavy Kaolin, Mentha Oil, Polyacrylic Acid, Purified Water. Polysorbate 80, Polyvinyl Alcohol, Sorbitol Solution, Sodium Polyacrylate, Tartaric Acid, Urea.

When Using This Product (When using this product)
  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use 1 hour prior to bathing or within 30 minutes after bathing
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days, or redness is present
  • Symptoms clear up and occur again within a few days
Principal Display Panel 5 Patch Packet (PRINCIPAL DISPLAY PANEL - 5 Patch Packet)

NDC 66761-325-05

TIGER BALM®

TIGER BALM®

PAIN RELIEVING

COOL PATCH

Advanced Hydrogel Patch Technology

Fast Acting Cooling Effect

For temporary relief of pains

  • Works Where it Hurts
  • Long Lasting
  • Easy to Apply and Remove
  • Convenient

5 PATCHES (4 x 2.75 inches each)


Advanced Ingredient Data


Raw Label Data

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