VITAMINERALS INC. CRYOGEL NATURAL PAIN RELIEVING - 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 Natural Pail Relieving Gel

Active Ingredient                        Purpose
Menthol 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.

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

-For external use only
-Flammable keep away from excessive heat or open flame

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

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

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, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Methylparaben, Disodium EDTA, Methylisothiazolinone, Sodium Hydroxide, Fragrance, Blue 1

Vitaminerals


Cryogel
Natural Pain Relieving Gel


Net Wt: 4 oz. (114 gm)

Front

Back

VITAMINERALS INC.  CRYOGEL NATURAL PAIN RELIEVING
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-4005
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)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERETH-26 (UNII: NNE56F2N14)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ARNICA MONTANA (UNII: O80TY208ZW)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56152-4005-21 in 1 BOX07/13/201006/29/2017
1NDC:56152-4005-1114 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/13/201006/29/2017
Labeler - Cosmetic Enterprises Ltd. (017701475)
Registrant - Cosmetic Enterprises Ltd. (017701475)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd.017701475manufacture(56152-4005)

Revised: 6/2017
 
Cosmetic Enterprises Ltd.