drug facts

drug facts
SPL v1
SPL
SPL Set ID 38dd20d8-7a31-41c5-9288-8d42e780b80a
Route
topical
Published
Effective Date 2010-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (2.96 mL) menthol (7.4 mL) methyl salicylate (22.2 mL)
Inactive Ingredients
water hydroxyethyl cellulose (4000 mpa.s for 1% aqueous solution) edetate disodium glyceryl monostearate sorbitan monostearate polysorbate 80 stearic acid potassium hydroxide phenoxyethanol caprylyl glycol ethylhexylglycerin hexylene glycol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2010-03-10

Purpose

.……..…….............….. Topical Analgesic ...……......……….....… Topical Analgesic .......….......… Topical Analgesic

Description

Camphor 4% Menthol 10% Methyl Salicylate 30%


Medication Information

Warnings

For external use only.

Do not use:

  • on wounds or damaged skin
  • with a heating pad

  • on a child under 12 years of age with arthritis like conditions


Uses

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

  • arthritis
  • strains
  • bruises
  • sprains
  • backache

Purpose


.……..…….............….. Topical Analgesic

...……......……….....… Topical Analgesic

.......….......… Topical Analgesic



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



Description

Camphor 4% Menthol 10% Methyl Salicylate 30%

Questions?

Call 1-859-422-7048

Section 51727-6
Water, Hydroxyethyl Cellulose, Edetate Disodium, Glyceryl Stearate Se,  Sorbitan Stearate, Stearic Acid,  Polysorbate 80, Potassium Hydroxide,  Phenoxyethanol (and) Caprylyl Glycol (and) Ethylhexylglycerin (and) Hexylene Glycol

Section 51945-4

Placeholder Text

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%



Keep Out of Reach of Children

In case of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.




Structured Label Content

Warnings

For external use only.

Do not use:

  • on wounds or damaged skin
  • with a heating pad

  • on a child under 12 years of age with arthritis like conditions


Uses

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

  • arthritis
  • strains
  • bruises
  • sprains
  • backache

Purpose


.……..…….............….. Topical Analgesic

...……......……….....… Topical Analgesic

.......….......… Topical Analgesic



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



Questions?

Call 1-859-422-7048

Section 51727-6 (51727-6)
Water, Hydroxyethyl Cellulose, Edetate Disodium, Glyceryl Stearate Se,  Sorbitan Stearate, Stearic Acid,  Polysorbate 80, Potassium Hydroxide,  Phenoxyethanol (and) Caprylyl Glycol (and) Ethylhexylglycerin (and) Hexylene Glycol

Section 51945-4 (51945-4)

Placeholder Text

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%



Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.




Advanced Ingredient Data


Raw Label Data

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