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Name:Vitaminerals Inc.cryogel Natural Pain Relieving
Manufacturer:Cosmetic Enterprises Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Cryogel Natural Pail Relieving Gel

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

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

image of back label

Vitaminerals

Cryogel

Natural Pain Relieving Gel

Net Wt: 4 oz. (114 gm)

image of front label


VITAMINERALS INC.  CRYOGEL NATURAL PAIN RELIEVING
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-4005
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 3 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56152-4005-2 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (56152-4005-1)
1 NDC:56152-4005-1 114 g in 1 BOTTLE This package is contained within the BOX (56152-4005-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 07/13/2010

Labeler - Cosmetic Enterprises Ltd. (017701475)
Registrant - Cosmetic Enterprises Ltd. (017701475)
Establishment
Name Address ID/FEI Operations
Cosmetic Enterprises Ltd. 017701475 manufacture

Revised: 07/2010 Cosmetic Enterprises Ltd.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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