DIAPEDIC FOOT TREATMENT

DIAPEDIC FOOT 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.

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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

ANASTASIA
DIABETIC PURE SKIN THERAPY
DIAPEDIC FOOT TREATMENT

RELIEVES NEUROPATHY PAIN
RESTORES SKIN HEALTH

NET WT 4OZ (113.4G)

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.

DIAPEDIC FOOT TREATMENT
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35813-373
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	1.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:35813-373-94	1 TUBE ( TUBE) in 1 BOX	contains a TUBE (35813-373-34)
1	NDC:35813-373-34	113.4 g in 1 TUBE	This package is contained within the BOX (35813-373-94)

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

Labeler - ANASTASIA MARIE LABORATORIES, INC. (789896834)

Registrant - ANASTASIA MARIE LABORATORIES, INC. (789896834)

Establishment
Name	Address	ID/FEI	Operations
American Pharmaceuticals and Cosmetics, Inc.		038023805	manufacture

Revised: 08/2011 ANASTASIA MARIE LABORATORIES, INC.