ALLURE ICE COLD ANALGESIC- menthol and camphor gel
Universal Distribution Center LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ALLURE ICE COLD ANALGESIC GEL

Active Ingredients

Menthol 1.0%

Camphor 0.5%

Purpose

Topical Analgesic

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

For external use only

Do not use

with other topical pain relievers
with heating pads or heating devices

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 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

If pregnant or breast-feeding,

ask a health professional before use

Keep out of the reach of children

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

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

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

PRINCIPAL DISPLAY PANEL

ALLURE ICE COLD GEL
ANALGESIC GEL
8 FL.OZ (226 GRAM)

ALLURE ICE COLD ANALGESIC
menthol and camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52000-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:52000-004-17	127 g in 1 TUBE
2	NDC:52000-004-18	170 g in 1 TUBE
3	NDC:52000-004-13	170 g in 1 BOTTLE, PLASTIC
4	NDC:52000-004-14	226 g in 1 BOTTLE, PLASTIC
5	NDC:52000-004-15	300 g in 1 BOTTLE, PLASTIC
6	NDC:52000-004-16	500 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/30/2012

Labeler - Universal Distribution Center LLC (019180459)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52000-004)