universal ice cold analgesic gel

SPL v3

SPL

SPL Set ID 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f

Route

topical

Published

Effective Date 2020-01-25

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 homopolymer type c (allyl pentaerythritol crosslinked) fd&c blue no. 1 edetate disodium isopropyl alcohol propylene glycol sodium hydroxide water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2020-01-25

Purpose

Topical Analgesic

Description

Menthol 1.25%

Medication Information

Warnings

For external use only

Do not use

with other topical pain relievers
with heating pads or heating devices

Uses

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

arthritis
simple backache
strains
bruises
sports injuries
sprains
provides cooling penetrating relief

Purpose

Topical Analgesic

Directions

clean affected area before applying product
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor

Other Information

store at controlled room temperature 20 to 25^oC (68 to 77^oF in a tightly closed container
do not use, pour, spill or store near heat or open flame

Inactive Ingredients

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

Description

Menthol 1.25%

Principal Display Panel

ICE COLD

ANALGESIC GEL

8 FL.OZ (227 GRAM)

Active Ingredients

Menthol 1.25%

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 right away

Structured Label Content

Warnings

For external use only

Do not use

with other topical pain relievers
with heating pads or heating devices

Uses

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

arthritis
simple backache
strains
bruises
sports injuries
sprains
provides cooling penetrating relief

Purpose

Topical Analgesic

Directions

clean affected area before applying product
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor

Other Information (Other information)

store at controlled room temperature 20 to 25^oC (68 to 77^oF in a tightly closed container
do not use, pour, spill or store near heat or open flame

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 (227 GRAM)

Active Ingredients

Menthol 1.25%

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 right away

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary relieves of minor aches and pains in muscles and joints associated with arthritis simple backache strains bruises sports injuries sprains provides cooling penetrating relief", "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 product adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor", "Other information": "store at controlled room temperature 20 to 25 o C (68 to 77 o F in a tightly closed container do not use, pour, spill or store near heat or open flame", "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 (227 GRAM)", "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 right away"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:23.573198 · Updated: 2026-03-14T23:01:53.224533