DIAPEDIC FOOT AND LEG TREATMENT- menthol lotion
ANASTASIA MARIE LABORATORIES, INC.

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.

----------

ACTIVE INGREDIENTS
MENTHOL 1.5%

PURPOSE

TOPICAL ANALGESIC

USES
TEMPORARILY RELIEVES PAIN OF:

DIABETIC NEUROPATHY
ARTHRITIS
MINOR ACHES

SOFTENS AND SOOTHES:

SKIN FISSURES
CALLUSES
CORNS
CRACKED HEALS

MOISTURIZES AND HELPS HEAL:

DRY SKIN
DIABETIC SKIN
SENSITIVE SKIN

RESTORES:

HEALTHY SKIN APPEARANCE
SKIN ELASTICITY

WARNINGS
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES

STOP USE AND ASK A DOCTOR IF IRRITATION DEVELOPS OR CONTINUES.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS
APPLY GENEROUSLY TO ALL SURFACES OF FEET, HEELS AND LEGS, MASSAGING UPWARD FROM TOES TO KNEES. SAFE FOR USE BETWEEN THE TOES. FOR BEST RESULTS, APPLY TWICE DAILY, MORNING AND BEDTIME, OR MORE FREQUENTLY AS NEEDED.

QUESTIONS OR COMMENTS? CALL 1.800.542.7546, OR PATIENTCARE@AMLAB.COM

INACTIVE INGREDIENTS: WHOLE LEAF ALOE BARBADENSIS EXTRACT, SAFFLOWER OIL, PARAFFIN, OCTYL STEARATE, OLIVE OIL, BUTYLENE GLYCOL, LANOLIN, METHYL SALICYLATE, BEESWAX, TRIETHANOLAMINE, TOCOTRIENOL, CETEARYL ALCOHOL/CETETH-20, LINOLEIC ACID/LINOLENIC ACID/ARACHIDONIC ACID (VITAMIN F), EUCALYPTUS OIL, BERGAMOT OIL, EVENING PRIMROSE OIL, ASCORBYL PALMITATE, TOCOPHEROL (VITAMIN E), ASCORBIC ACID (VITAMIN C), RETINYL PALMITATE (VITAMIN A), PANTHENOL, MENTHOL, CAMPHOR, ALLANTOIN, GLYCERYL STEARATE, PEG-100 STEARATE, STEARETH-2, STEARETH-21, STEARIC ACID, CARBOMER, HYDROLYZED GLYCOSAMINOGLYCANS, CETYL ALCOHOL, XANTHAN GUM, SODIUM PCA, PHENOXYETHANOL, CAPRYLYL GLYCOL.

Anastasia Diapedic Foot Treatment jar label 9-28-12 Anastasia Diapedic Box 9-12-12

DIAPEDIC FOOT AND LEG TREATMENT
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:35813-374
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (MENTHOL)	MENTHOL	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE
SAFFLOWER
PARAFFIN
OCTYL STEARATE
OLIVE OIL
BUTYLENE GLYCOL
LANOLIN
METHYL SALICYLATE
YELLOW WAX
TROLAMINE
.ALPHA.-TOCOTRIENOL
CETOSTEARYL ALCOHOL
CETETH-20
LINOLEIC ACID
LINOLENIC ACID
ARACHIDONIC ACID
EUCALYPTUS OIL
BERGAMOT OIL
EVENING PRIMROSE OIL
ASCORBYL PALMITATE
TOCOPHEROL
ASCORBIC ACID
VITAMIN A PALMITATE
PANTHENOL
CAMPHOR (SYNTHETIC)
ALLANTOIN
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
STEARETH-2
STEARETH-21
STEARIC ACID
CARBOMER 934
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW)
CETYL ALCOHOL
XANTHAN GUM
SODIUM PYRROLIDONE CARBOXYLATE
PHENOXYETHANOL
CAPRYLYL GLYCOL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35813-374-34	113.4 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/31/2011

Labeler - ANASTASIA MARIE LABORATORIES, INC. (789896834)

Registrant - ANASTASIA MARIE LABORATORIES, INC. (789896834)

Revised: 10/2012

Document Id: 97896738-6e36-44e3-b2d4-5cfaa2fc5305

Set id: c0698904-9ef6-4ef6-a548-cfe08d08d5f5

Version: 3

Effective Time: 20121017

ANASTASIA MARIE LABORATORIES, INC.