ICE COLD ANALGESIC- menthol gel

Ice Cold Analgesic by

Drug Labeling and Warnings

Ice Cold Analgesic by is a Otc medication manufactured, distributed, or labeled by North & South Wholesalers LLC, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol             1.25%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & 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

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

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

WHEN USING

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

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

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

DOSAGE & 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

SPL UNCLASSIFIED SECTION

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.  

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic

NET WT.8 OZ (227g)

INGREDIENTS AND APPEARANCE

ICE COLD ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70201-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70201-005-08	227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/19/2018

Labeler - North & South Wholesalers LLC (004948495)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(70201-005)