CALYPXO PAIN RELIEF- methyl salicylate and menthol cream
Enovachem Manufacturing

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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Drugs Facts

Active Ingredients

Methyl Salicylate……….10.00%

Menthol…………………...3.00%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

Warning

For external use only.

Avoid contact with eyes and mucous membranes.

Do not bandage tightly or cover treated areas.

Do not use with heating pad.

Do not apply to open wounds or damages skin.

A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.

If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children. If swallowed, consult physician.

If pregnant or breast feeding, contact physician prior to use.

Directions

For adults apply directly to effected area. Repeat as necessary, but do not use more than 3-4 times daily.

Other Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl Sulfate, Triethanolamine.

Principal Display Panel – Front Label

NDC 76420-0450-12

Calypxo

Pain Relief Cream

4 OZ (113g)

Distributed by:

Enovachem Manufacturing

Torrance, CA 90501

(310) 218-4146

CALYPXO PAIN RELIEF
methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:76420-450
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Methyl Salicylate (SALICYLIC ACID)	Methyl Salicylate	10 g in 100 g
Menthol (Menthol)	Menthol	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
Aloe Vera Leaf
Water
Cetyl Alcohol
Diazolidinyl Urea
Isopropyl Myristate
MethylParaben
POLYETHYLENE GLYCOL 400
PropylParaben
Propylene Glycol
Sodium lauryl Sulfate
TROLAMINE

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76420-450-12	113 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/15/2014

Labeler - Enovachem Manufacturing (059888437)

Name	Address	ID/FEI	Business Operations
Establishment
Enovachem Manufacturing		059888437	MANUFACTURE(76420-450)

Revised: 1/2014

Document Id: 56a77c02-920d-4d12-862a-d30c6e9f70b5

Set id: bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6

Version: 1

Effective Time: 20140116

Enovachem Manufacturing