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DIAPEDIC FOOT TREATMENT

Dosage form: lotion
Ingredients: MENTHOL 1.5mg in 1g
Labeler: ANASTASIA MARIE LABORATORIES, INC.
NDC Code: 35813-373

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.

DIAPEDIC FOOT TREATMENT

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:35813-373
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:35813-373-941 JAR (JAR) in 1 BOX
1NDC:35813-373-34113.4 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2011
Labeler - ANASTASIA MARIE LABORATORIES, INC. (789896834)
Registrant - ANASTASIA MARIE LABORATORIES, INC. (789896834)
Establishment
NameAddressID/FEIOperations
American Pharmaceuticals and Cosmetics, Inc.038023805manufacture

Revised: 10/2011
Document Id: 6e2f940f-8aab-430a-aef6-cf358737b649
Set id: b6e317e3-dbb3-42e8-8f36-fadf16ba717f
Version: 4
Effective Time: 20111006
 
ANASTASIA MARIE LABORATORIES, INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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