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


Cryogel Lavender Breeze Natural Pain Relieving Gel

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

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:56152-4007
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
ISOPROPYL ALCOHOL  
POLYOXYL 40 HYDROGENATED CASTOR OIL  
PROPYLENE GLYCOL  
METHYLPARABEN  
EDETATE DISODIUM  
METHYLISOTHIAZOLINONE  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56152-4007-2 1 TUBE ( TUBE) in 1 BOX contains a TUBE (56152-4007-1)
1 NDC:56152-4007-1 114 g in 1 TUBE This package is contained within the BOX (56152-4007-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/14/2010

Labeler - Cosmetic Enterprises Ltd. (017701475)
Registrant - Vitaminerals, Inc. (008349722)
Establishment
Name Address ID/FEI Operations
Cosmetic Enterprises Ltd. 017701475 manufacture

Revised: 09/2010 Cosmetic Enterprises Ltd.



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


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