ICE COLD ANALGESIC GEL- menthol and camphor gel

Ice Cold Analgesic Gel by

Drug Labeling and Warnings

Ice Cold Analgesic Gel by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Menthol             1.0%

Camphor            0.5%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

for the temporary relief  of minor aches and pains in muscles and joints associated with:

• simple backache
• strains
• sprains
• sports injuries
• arthritis
• bruises

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 eyes
• do not apply to wounds or damaged skin
• do not bandage tightly

STOP USE

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

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

INACTIVE INGREDIENT

Inactive ingredients

benzyl alcohol, butylated hydroxytoluene, carbopol, colour brillient blue, creasmer RH 40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water and sodium hydroxide

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic
NET WT.8 OZ (227g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ICE COLD ANALGESIC GEL 
menthol and camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOMER 934 (UNII: Z135WT9208)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-013-17	127 g in 1 TUBE
2	NDC: 52000-013-18	170 g in 1 TUBE
3	NDC: 52000-013-13	170 g in 1 BOTTLE, PLASTIC
4	NDC: 52000-013-14	227 g in 1 BOTTLE, PLASTIC
5	NDC: 52000-013-15	300 g in 1 BOTTLE, PLASTIC
6	NDC: 52000-013-16	500 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/15/2013

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52000-013)