Vitaminerals Inc. Cryogel Natural Pain Relieving

Dosage form: gel
Ingredients: MENTHOL 3g in 100g
Labeler: Cosmetic Enterprises Ltd.
NDC Code: 56152-4005

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.

Cryogel Natural Pail Relieving Gel

Active Ingredient               Purpose

Menthol 3%                      Topical Analgesic

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 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

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

If pregnant or breast-feeding, as a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses: temporarily relieves the minor aches and pains of muscles and joints associated with strains, sprains, bruises, simple backache, arthritis

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)

VITAMINERALS INC.  CRYOGEL NATURAL PAIN RELIEVING
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-4005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3 g  in 100 g
Packaging
#Item CodePackage Description
1NDC:56152-4005-21 BOTTLE (BOTTLE) in 1 BOX
1NDC:56152-4005-1114 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33307/13/2010
Labeler - Cosmetic Enterprises Ltd. (017701475)
Registrant - Cosmetic Enterprises Ltd. (017701475)
Establishment
NameAddressID/FEIOperations
Cosmetic Enterprises Ltd.017701475manufacture

Revised: 07/2010
 
Cosmetic Enterprises Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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