Tiger Balm ®

Tiger Balm ®
SPL v11
SPL
SPL Set ID 2e7638c6-e1ce-4e2f-bd50-52fbce5a138e
Route
TOPICAL
Published
Effective Date 2025-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (150 mg) Menthol, Unspecified Form (50 mg) Camphor (synthetic) (30 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Diazolidinyl Urea Glycerin Methyl Glucose Dioleate Methylparaben Propylparaben Propylene Glycol Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-05-01 Until 2029-04-30

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

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 immediately.

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
Methyl Salicylate 15% Topical Analgesic
Menthol 5% Topical Analgesic
Camphor 3% Topical Analgesic
Warnings

For external use only.

Questions

(925) 292-3888

Directions
  • For adults and children over 12 years of age, 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
  • 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

Diazolidinyl Urea, Glycerin, Methyl Glucose Dioleate, Methyl Paraben, Carbomer, Propyl Paraben, Propylene Glycol, Purified Water, Triethanolamine.

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.
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.
Principal Display Panel 60g Tube Box

TIGER BALM ®

NDC 66761-129-60

ACTIVE

MUSCLE

RUB

  • PRE-SPORTS WARM-UP
  • RELIEF FOR SORE MUSCLES
  • NON-GREASY PAIN RELIEF

    CREAM

NET WT. 2 OZ. (60G)


Structured Label Content

Uses

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

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 immediately.

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
Methyl Salicylate 15% Topical Analgesic
Menthol 5% Topical Analgesic
Camphor 3% Topical Analgesic
Warnings

For external use only.

Questions

(925) 292-3888

Directions
  • For adults and children over 12 years of age, 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
  • 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

Diazolidinyl Urea, Glycerin, Methyl Glucose Dioleate, Methyl Paraben, Carbomer, Propyl Paraben, Propylene Glycol, Purified Water, Triethanolamine.

When Using This Product (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.
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
  • Pain clears up and then recurs a few days later.
Principal Display Panel 60g Tube Box (PRINCIPAL DISPLAY PANEL - 60G Tube Box)

TIGER BALM ®

NDC 66761-129-60

ACTIVE

MUSCLE

RUB

  • PRE-SPORTS WARM-UP
  • RELIEF FOR SORE MUSCLES
  • NON-GREASY PAIN RELIEF

    CREAM

NET WT. 2 OZ. (60G)


Advanced Ingredient Data


Raw Label Data

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