Astonea Cold Ice Gel

SPL v3

SPL

SPL Set ID e5c0c190-042d-616f-e053-2995a90a25d2

Route

TOPICAL

Published

Effective Date 2019-04-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (4.54 g)

Inactive Ingredients

Ammonia Isopropyl Alcohol Cupric Sulfate Thymol Fd&c Blue No. 1 Water Sodium Hydroxide Carbomer Homopolymer, Unspecified Type Magnesium Sulfate, Unspecified

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-04-08

Description

Menthol 2.0%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 2.0%

Uses

for temporary relief of minor aches and pains in muscles and joints associated with:
simple backaches,
strains
sprains
sports injuries
arthritis
bruises

Section 51945-4

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

Active Ingredient

Menthol 2.0%

Inactive Ingredients

ammonium hydroxide, carbomer, cupric sulfate, FD&C Blue No. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

When Using This Product

do not use in or near eyes
do not apply to wounds or damaged skin
do not bandage tightly

If Pregnant Or Breastfeeding

ask a health professional before use

Stop Use and Ask A Doctor If

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
redness or irritation develops

Keep Out of Reach of Children

If swallowed get Medical Help or contact a Poison Control Center right away

Structured Label Content

Uses

for temporary relief of minor aches and pains in muscles and joints associated with:
simple backaches,
strains
sprains
sports injuries
arthritis
bruises

Section 51945-4 (51945-4)

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

Active Ingredient

Menthol 2.0%

Inactive Ingredients

ammonium hydroxide, carbomer, cupric sulfate, FD&C Blue No. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

When Using This Product (When using this product)

do not use in or near eyes
do not apply to wounds or damaged skin
do not bandage tightly

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
redness or irritation develops

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

[{"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CUPRIC SULFATE", "unii": "LRX7AJ16DT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "4.54", "strengthDenominator": "227", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SULFATE, UNSPECIFIED", "unii": "DE08037SAB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for temporary relief of minor aches and pains in muscles and joints associated with: simple backaches, strains sprains sports injuries arthritis bruises", "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", "Active Ingredient": "Menthol 2.0%", "Inactive Ingredients": "ammonium hydroxide, carbomer, cupric sulfate, FD&C Blue No. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water", "When using this product": "do not use in or near eyes do not apply to wounds or damaged skin do not bandage tightly", "If pregnant or breastfeeding": "ask a health professional before use", "Stop use and ask a doctor if": "condition worsens symptoms last more than 7 days or clear up and occur again within a few days redness or irritation develops", "KEEP OUT OF REACH OF CHILDREN": "If swallowed get Medical Help or contact a Poison Control Center right away"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:12.958200 · Updated: 2026-03-14T23:03:09.210552