cold and heat pain relieving cream

cold and heat pain relieving cream
SPL v2
SPL
SPL Set ID dbaa8066-860e-473e-820f-11f0db80180f
Route
topical
Published
Effective Date 2018-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 g) salicylic acid (30 g)
Inactive Ingredients
cetyl esters wax oleth-3 phosphate stearic acid water trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2018-08-09
Purpose

Topical analgesic

Description

Drug Facts

Medication Information

Warnings

For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises

  • cramps
Purpose

Topical analgesic

Directions

adults and children over 12 years:

  • apply generously to affected area

  • massage into painful area until thoroughly absorbed into skin

  • repeat as necessary, but not more than 4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients

ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)

Description

Drug Facts

Principal Display Panel

Section 42229-5

Drug Facts

Active Ingredient

Menthol 10%

Methyl salicylate 30%

When Using This Product
  • use only as directed

  • do not bandage tightly or use with a heating pad

  • avoid contact with eyes or mucous membranes

  • do not apply to wounds or damaged, broken or irritated skin
Stop Use and Ask A Doctor If
  • condition worsens

  • redness is present

  • irritation develops

  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Warnings

For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises

  • cramps
Purpose

Topical analgesic

Directions

adults and children over 12 years:

  • apply generously to affected area

  • massage into painful area until thoroughly absorbed into skin

  • repeat as necessary, but not more than 4 times daily

children 12 years or younger: ask a doctor

Inactive Ingredients (Inactive ingredients)

ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 42229-5 (42229-5)

Drug Facts

Active Ingredient (Active ingredient)

Menthol 10%

Methyl salicylate 30%

When Using This Product (When using this product)
  • use only as directed

  • do not bandage tightly or use with a heating pad

  • avoid contact with eyes or mucous membranes

  • do not apply to wounds or damaged, broken or irritated skin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens

  • redness is present

  • irritation develops

  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:37.624553 · Updated: 2026-03-14T22:55:12.436150