Tiger Balm®

Tiger Balm®
SPL v3
SPL
SPL Set ID ca601b02-e9be-4d8d-a384-c62553302ceb
Route
TOPICAL
Published
Effective Date 2024-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (160 mg) Levomenthol (48 mg) Capsicum (32 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Eucalyptus Oil Glycerin Kaolin Mentha Arvensis Leaf Oil Polysorbate 80 Propylene Glycol Carboxymethylcellulose Sodium, Unspecified Sodium Polyacrylate (8000 Mw) Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

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 a 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 160mg / patch Topical Analgesic
Menthol 48mg / patch Topical Analgesic
Capsicum Extract 32mg / patch Topical Analgesic
Warnings

FOR EXTERNAL USE ONLY.

Directions
  • Adults and children 12 years and over apply to the 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
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

Aluminium glycinate, eucalyptus oil, glycerin, hydrotalcite, kaolin, mentha oil, polysorbate 80, polyacrylic acid solution, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, sorbitol solution, water

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
  • Symptoms clears up and occur again within a few days
Principal Display Panel 2 Patch Pouch

2 PATCH PACK

X WIDER SIZE*

*As compared to our

Regular Size Patch (4" x 2.75")

NDC 66761-354-02

TIGER BALM®

TIGER BALM®

PAIN RELIEVING

PATCH

Advanced Hydrogel Patch Technology

For temporary relief of pains

  • Convenient And Not Messy
  • Works Where It Hurts
  • Long Lasting

2 PATCHES (3.9 x 5.5 inches each)

LOT:

EXP:


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 a 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 160mg / patch Topical Analgesic
Menthol 48mg / patch Topical Analgesic
Capsicum Extract 32mg / patch Topical Analgesic
Warnings

FOR EXTERNAL USE ONLY.

Directions
  • Adults and children 12 years and over apply to the 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
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

Aluminium glycinate, eucalyptus oil, glycerin, hydrotalcite, kaolin, mentha oil, polysorbate 80, polyacrylic acid solution, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, sorbitol solution, water

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
  • Symptoms clears up and occur again within a few days
Principal Display Panel 2 Patch Pouch (PRINCIPAL DISPLAY PANEL - 2 Patch Pouch)

2 PATCH PACK

X WIDER SIZE*

*As compared to our

Regular Size Patch (4" x 2.75")

NDC 66761-354-02

TIGER BALM®

TIGER BALM®

PAIN RELIEVING

PATCH

Advanced Hydrogel Patch Technology

For temporary relief of pains

  • Convenient And Not Messy
  • Works Where It Hurts
  • Long Lasting

2 PATCHES (3.9 x 5.5 inches each)

LOT:

EXP:


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)