Ice Cold Analgesic Gel

Drug Facts

Composition & Product

Active Ingredients

Menthol (1.25 g)

Inactive Ingredients

Benzyl Alcohol Butylated Hydroxytoluene Camphor (synthetic) Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Edetate Disodium Fd&c Blue No. 1 Isopropyl Alcohol Polyoxyl 40 Hydrogenated Castor Oil Propylene Glycol Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-08-19

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:
arthritis
simple backache
strains
bruises
sports injuries
sprains
provides cooling penetrating relife

Dosage and Administration

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

Description

Active Ingredient Menthol 1.25%

Section 42229-5

Other information

store at controlled room temperature 20 to 25°C (68 to 77°F) in a tightly closed container.
do not use, pour, spill or store near heat or open flame.

Section 50565-1

Keep out of the reach of children

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

Section 50566-9

Stop use and ask a doctor if

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

Section 50567-7

When using this product

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

Section 50570-1

Do not use

with other topical pain relievers
with heating pads or heating devices

Section 51727-6

Inactive Ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water.

Section 51945-4

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic

NET WT.8 OZ (227g)

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active Ingredient

Menthol 1.25%

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:
arthritis
simple backache
strains
bruises
sports injuries
sprains
provides cooling penetrating relife

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Other information

store at controlled room temperature 20 to 25°C (68 to 77°F) in a tightly closed container.
do not use, pour, spill or store near heat or open flame.

Section 50565-1 (50565-1)

Keep out of the reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

Section 50567-7 (50567-7)

When using this product

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

Section 50570-1 (50570-1)

Do not use

with other topical pain relievers
with heating pads or heating devices

Section 51727-6 (51727-6)

Inactive Ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic

NET WT.8 OZ (227g)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient

Menthol 1.25%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves minor aches and pains of muscles and joints associated with: arthritis simple backache strains bruises sports injuries sprains provides cooling penetrating relife", "34068-7": "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", "34071-1": "Warnings For external use only", "42229-5": "Other information store at controlled room temperature 20 to 25°C (68 to 77°F) in a tightly closed container. do not use, pour, spill or store near heat or open flame. ", "50565-1": "Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clean up and occur again within a few days redness or irritation develops", "50567-7": "When using this product do not use in or near the eyes do not apply to wounds or damaged skin do not bandage tightly", "50570-1": "Do not use with other topical pain relievers with heating pads or heating devices", "51727-6": "Inactive Ingredients benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water.", "51945-4": "PRINCIPAL DISPLAY PANEL ICE COLD ANALGESIC GEL Topical Analgesic NET WT.8 OZ (227g)", "53414-9": "If pregnant or breast-feeding, ask a health professional before use", "55105-1": "Purpose Topical Analgesic", "55106-9": "Active Ingredient Menthol 1.25%"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information