Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 24259fe5-c725-17e0-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Salicylic Acid (15 g)
Inactive Ingredients
Carbomer Homopolymer Type C Cetyl Alcohol Glycerin Glyceryl Monostearate Isopropyl Myristate Methylparaben Peg-15 Glyceryl Stearate Propylparaben Water Stearic Acid Stearyl Alcohol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-11-09

Description

Menthol 10% Methyl salicylate 15%

Purpose

Topical analgesic Topical analgesic


Medication Information

Purpose

Topical analgesic

Topical analgesic

Description

Menthol 10% Methyl salicylate 15%

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Directions
  • use only as directed
  • adults and 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: ask a doctor

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • If you are allergic any of the ingredients
  • on a child under 12 years of age with arthritis-like conditions

Package Label

Discount Drug Mart Greaseless Muscle Rub

Other Information
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients

Menthol 10%

Methyl salicylate 15%

Inactive Ingredients

carbomer 940, cetyl alcohol, glycerin, glycerol monostearate, isoprophyl myristate, methylparaben, PEG 15 glyceryl stearate, propylparaben, purified water, stearic acid, stearyl alcohol, trolamine

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Ask A Doctor Before Use If You Have

redness over the affected area.

Keep Out of Reach of Children to Avoid Accidental Ingestion.

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


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Purpose

Topical analgesic

Topical analgesic

Warnings

For external use only

Directions
  • use only as directed
  • adults and 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: ask a doctor

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • If you are allergic any of the ingredients
  • on a child under 12 years of age with arthritis-like conditions

Package Label (Package label)

Discount Drug Mart Greaseless Muscle Rub

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients (Active ingredients)

Menthol 10%

Methyl salicylate 15%

Inactive Ingredients (Inactive ingredients)

carbomer 940, cetyl alcohol, glycerin, glycerol monostearate, isoprophyl myristate, methylparaben, PEG 15 glyceryl stearate, propylparaben, purified water, stearic acid, stearyl alcohol, trolamine

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

redness over the affected area.

Keep Out of Reach of Children to Avoid Accidental Ingestion. (Keep out of reach of children to avoid accidental ingestion.)

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


Advanced Ingredient Data


Raw Label Data

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