Universal Ice Cold Analgesic Gel

Universal Ice Cold Analgesic Gel
SPL v1
SPL
SPL Set ID b65a33b5-db06-e0ae-e053-2a95a90af0ea
Route
TOPICAL
Published
Effective Date 2020-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.25 g)
Inactive Ingredients
Camphor (synthetic) Benzyl Alcohol Butylated Hydroxytoluene Carbomer 940 Fd&c Blue No. 1 Edetate Disodium Isopropyl Alcohol Propylene Glycol Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-05-01
Description

Menthol 1.25%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 1.25%

Uses

Temporary relieves of minor aches and pains in muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • bruises
  • sports injuries
  • sprains


Warnings

For external use only

Do not use

  • with other topical pain relievers
  • with heating pads or heating devices

Directions
  • clean affected area before applying products

  • adults and children 2 years of age and older
  • apply to affected area not more than 3 to 4 times daily.
Active Ingredients

Menthol 1.25%

Inactive Ingredients

Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

Principal Display Panel

ICE COLD

ANALGESIC GEL

8 FL.OZ (237 ml)







When Using This Product
  • do not use in or near the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use and Ask Doctor If
  • condition worsens

  • symptoms last more than 7 days or clean up and occur again within a few days
  • redness or irritation develops

If Pregnant Or Breast Feeding,
  • ask a health professional before use
Keep Out of the Reach of Children

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

Structured Label Content

Uses

Temporary relieves of minor aches and pains in muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • bruises
  • sports injuries
  • sprains


Purpose

Topical Analgesic

Warnings

For external use only

Do not use

  • with other topical pain relievers
  • with heating pads or heating devices

Directions
  • clean affected area before applying products

  • adults and children 2 years of age and older
  • apply to affected area not more than 3 to 4 times daily.
Active Ingredients

Menthol 1.25%

Inactive Ingredients (Inactive ingredients)

Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ICE COLD

ANALGESIC GEL

8 FL.OZ (237 ml)







When Using This Product (When using this product)
  • do not use in or near the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • condition worsens

  • symptoms last more than 7 days or clean up and occur again within a few days
  • redness or irritation develops

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
  • ask a health professional before use
Keep Out of the Reach of Children (Keep out of the reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:09.613546 · Updated: 2026-03-14T22:59:02.436223