UNIVERSAL ICE COLD ANALGESIC GEL

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd.
Effective date
2020-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:11

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Menthol 1.25%

Purpose

Topical Analgesic

Uses

Uses

Temporary relieves of minor aches and pains in muscles and joints associated with arthritis simple backache strains bruises sports injuries sprains

Warnings

Warnings

For external use only Do not use with other topical pain relievers with heating pads or heating devices

If pregnant or breast-feeding,

ask a health professional before use

Directions And Dosage

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.

Other Label Information

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)

Label Images#

ice-cold-gel-tube
ice-cold-gel-tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866128menthol 1.25 % Topical GelPSN1
866128menthol 0.0125 MG/MG Topical GelSCD1
866128menthol 1.25 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47046-159-012022-01-28C16284748780-1d6a99b39-b4e2-a426-e053-dadaa90af4c2UNIVERSAL ICE COLD ANALGESIC GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-159-01Universal Ice Cold Analgesic237 mL in 1 TUBEGEL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-159UNIVERSAL ICE COLD ANALGESIC (MENTHOL) GEL [ANICARE PHARMACEUTICALS PVT. LTD.]1Legacy NDC, 1 package rows20201215_b65a33b5-db06-e0ae-e053-2a95a90af0ea.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47046-15947046-159-01

Ingredients#

Complete SPL Sections#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relieves of minor aches and pains in muscles and joints associated with arthritis simple backache strains bruises sports injuries sprains

Warnings

WARNINGS SECTION

For external use only Do not use with other topical pain relievers with heating pads or heating devices

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL 8 FL.OZ (237 ml)

Source Document#

Source XML