BIO-SCRIPTIVES EXTREME AF - tolnaftate cream 
BioChemics, 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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Drug Facts

Active Ingredients

Tolnaftate 1%

Purpose

Antifungal

Uses

■  Proven clinically effective in the treatment of athlete's foot.
■  Relieves itching and burning feet.

Warnings

■  Do not use on children under 2 years of age.
■  Do not use for diaper rash.
■  For external use only.
■  Avoid contact with eyes.

Stop use and ask a doctor if

Directions

■  Wash the feet and dry thoroughly.
■  Apply a thin layer of product to the feet once or twice daily (morning and/or night).
■  Supervise children in the use of this product.
■  Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
■  Do not use if safety seal is broken.


Inactive Ingredients

Purified Water, Glyceryl Stearate SE, Stearyl Alcohol, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Olive Oil, Menthol, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, L-Arginine hydroxide, PEG-40 Hdrogenated Castor Oil, Eucalyptus Globulus, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Althaea Officinalis Extract, Echinacea Angustifolia Extract, Allantoin, Tagetes Erecta Extract, Sodium Chloride, Ascophyllum Nodosum Extract, Xanthan Gum, Azadirachta Indica (Neem) Seed Oil, Methylisothiazolinone

Reference

Distributed by BioChemics dba Bio-Scriptives

99 Rosewood Dr. #260 - Danvers, MA 01923

978-750-0790


Labeling


ExtremeAR Front Label

ExtremeAR Back Label

Keep out of reach of children

Enter section text here

BIO-SCRIPTIVES EXTREME AF 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE.56 g  in 56.69 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALLANTOIN (UNII: 344S277G0Z)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
TAGETES ERECTA FLOWER (UNII: UH5X33P33E)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MENTHOL (UNII: L7T10EIP3A)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60608-013-0056.69 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/27/2011
Labeler - BioChemics, Inc. (802946426)
Establishment
NameAddressID/FEIBusiness Operations
Coastal Products Company782445688manufacture

Revised: 7/2011
Document Id: 21203d45-e7b4-4bb2-a475-f8711a6ba65d
Set id: e901c834-dcac-4d12-85f2-655ca9239cfe
Version: 6
Effective Time: 20110727
 
BioChemics, Inc.