NATURAL PAIN RELIEVING LAVENDER BREEZE CRYOGEL- menthol gel 
Cosmetic Enterprises Ltd.

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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Cryogel Lavender Breeze Natural Pain Relieving Gel


Active ingredient                   purpose
Methol 3%                   Topical Analgesic

Uses Temporarily relieves the minor aches and pains of muscles and joints associated with

Strains

Sprains

Bruises

Simple backache

Arthritis

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately

When using this product:

use only as directed

do not bandage

do not use with a heating pad

do not use on a child under 12 years of age

do not apply to wounds or damaged skin

avoid contact with eyes and mucus membranes

Warnings

For external use only

Flammable keep away from excessive heat or open flame


Stop use and consult a doctor if:

The condition worsens or persists for more than 7 days

symptoms clear up and occur again within a few days

excessive skin irritation develops

Directions

adults and children over 12 years of age, apply to affected area 3 to 4 times daily

Children under 12, consult a doctor

Inactive ingredients

water, Isopropyl alcohol, PEG-40 hydrogenated castor oil, ethoxydiglycol, propylene glycol, glycereth-26, MSM, Arnica ext, Hamamelis virginiana ext, camphor, capsicum annuum, acylates/C10-30 alkyl acrylate crosspolymer, methylparaben, disodium EDTA, methylisothiazolinone, sodium hydroxide, fragrance, blue 1.

Image of back label

Cryogel Lavender Breeze Natural Pain Relieving Gel

Net Wt: 4 oz. (144 gm)

Image of front label

NATURAL PAIN RELIEVING LAVENDER BREEZE  CRYOGEL
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-4007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56152-4007-21 in 1 BOX09/14/201006/29/2017
1NDC:56152-4007-1114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/14/201006/29/2017
Labeler - Cosmetic Enterprises Ltd. (017701475)
Registrant - Vitaminerals, Inc. (008349722)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd.017701475manufacture(56152-4007)

Revised: 6/2017
Document Id: fab652ee-6893-4a1a-9faa-e87733cb5b7a
Set id: f031a20d-64f5-4427-b52e-78562ac3c893
Version: 3
Effective Time: 20170629
 
Cosmetic Enterprises Ltd.