Drug Facts - Equate Cool And Heat

Drug Facts - Equate Cool And Heat
SPL v4
SPL
SPL Set ID c5ab2426-eeca-4ba4-9f00-7790d2176471
Route
TOPICAL
Published
Effective Date 2020-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (100 mg) Salicylic Acid (300 mg)
Inactive Ingredients
Glyceryl Monostearate Isoceteth-20 Poloxamer 407 Water Sodium Lauryl Sulfate Sorbitan Monostearate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-17

Description

Menthol 10% Methyl salicylate 30%

Purpose

Menthol - Topical analgesic Methyl salicylate - Topical analgesic


Medication Information

Purpose

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Description

Menthol 10% Methyl salicylate 30%

Uses

temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • bruises
  • muscle strains
  • muscle sprains
Warnings

For external use only

Questions

Call: 1-888-287-1915

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Active Ingredient

Menthol 10%

Methyl salicylate 30%

Inactive Ingredients

glyceryl stearate, isoceteth-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Principal Display Panel
When Using This Product
  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with a heating pad or apply external heat
Stop Use and Ask A Doctor If
  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Uses

temporarily relieves minor aches and pains of muscles and joints due to:

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

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Warnings

For external use only

Questions

Call: 1-888-287-1915

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Active Ingredient (Active ingredient)

Menthol 10%

Methyl salicylate 30%

Inactive Ingredients

glyceryl stearate, isoceteth-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Principal Display Panel
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 or damaged skin
  • do not bandage tightly
  • do not use with a heating pad or apply external heat
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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