amerisource bergen muscle rub drug facts

amerisource bergen muscle rub drug facts
SPL v1
SPL
SPL Set ID 09ff2eb2-7d4a-468c-8cb1-ffeff0754c97
Route
topical
Published
Effective Date 2009-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (4 g) menthol (10 g) salicylic acid (30 g)
Inactive Ingredients
carbomer homopolymer type c edetate disodium glyceryl monostearate polyoxyl 100 stearate polysorbate 80 potassium hydroxide water stearic acid trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2005-08-02

Purpose

Topical analgesic

Description

Camphor 4% Menthol 10% Methyl salicylate 30%


Medication Information

Warnings

For external use only

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

Directions
  • adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician
Other Information
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

carbomer 940, edetate disodium, glyceryl monostearate, lanolin anhydrous, PEG-100 stearate, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Description

Camphor 4% Menthol 10% Methyl salicylate 30%

Principal Display Panel

Compare to the Active Ingredients of Ultra Strength Bengay®

Ultra Strength

Deep Penetrating Pain Relief

Fast Relief from Minor Arthritis, Backache, Muscle & Joint Pain

With Three Pain Relieving Ingredients

Muscle Rub

Non-Greasy

Pain Relieving Cream

Muscle Rub Carton
Do Not Use
  • other than as directed
  • with a heating pad (may blister skin)
  • on children under 12 years of age
Active Ingredient

Camphor 4%

Menthol 10%

Methyl salicylate 30%

When Using This Product
  • avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • skin redness or excessive irritation of the skin develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children to Avoid Accidental Poisoning.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

Directions
  • adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician
Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer 940, edetate disodium, glyceryl monostearate, lanolin anhydrous, PEG-100 stearate, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Principal Display Panel

Compare to the Active Ingredients of Ultra Strength Bengay®

Ultra Strength

Deep Penetrating Pain Relief

Fast Relief from Minor Arthritis, Backache, Muscle & Joint Pain

With Three Pain Relieving Ingredients

Muscle Rub

Non-Greasy

Pain Relieving Cream

Muscle Rub Carton
Do Not Use (Do not use)
  • other than as directed
  • with a heating pad (may blister skin)
  • on children under 12 years of age
Active Ingredient (Active ingredient)

Camphor 4%

Menthol 10%

Methyl salicylate 30%

When Using This Product (When using this product)
  • avoid contact with the eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • skin redness or excessive irritation of the skin develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children to Avoid Accidental Poisoning. (Keep out of reach of children to avoid accidental poisoning.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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