CRYOGEL ISLAND RAIN NATURAL PAIN RELIEVING  VITAMINERALS - 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 Pain Relieving Gel Island Rain

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

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

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

Warning:

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 a heating pad

Do not use on a child under 12 years of age

Do no apply to wounds or damaged skin

Avoid contact with eyes and mucus membranes

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, alcohol, PEG-40 hydrogenated castor oil, ethoxydiglycol, propylene glycol, glycereth-26, MSM, Arnica Montana Ext, aloe, Camellia Ext, Hammamelis Ext, camphor, ascorbal palmitate, tocopheryl acetate, capsicuum annum, acrylates/C10-30 alkyl acrylate crosspolymer, methylparaben, disodium EDTA, metjylisothiazolinone, sodium hydroxide, fragrance, blue 1, yellow 5.

Image of back label

Cryogel Island Rain Natural Pain Relieving Gel

Nt Wt: 4 oz. (114 gm)

Image of front label

CRYOGEL ISLAND RAIN NATURAL PAIN RELIEVING   VITAMINERALS
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-4006
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:56152-4006-1114 g in 1 TUBE; Type 0: Not a Combination Product09/14/201006/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/14/201006/29/2017
Labeler - Cosmetic Enterprises Ltd. (017701475)
Registrant - Cosmetic Enterprises Ltd. (017701475)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd. 017701475manufacture(56152-4006)

Revised: 6/2017
 
Cosmetic Enterprises Ltd.