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Name:Bio-scriptives Extreme Af
Manufacturer:Biochemics, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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

  • irritation occurs or if there is no improvement within 4 weeks.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:60608-013
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE .56 g  in 56.69 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE A  
PROPYLENE GLYCOL  
XANTHAN GUM  
WATER  
ARGININE HYDROCHLORIDE  
SODIUM CHLORIDE  
ALOE VERA LEAF  
ALLANTOIN  
ALTHAEA OFFICINALIS ROOT  
ECHINACEA ANGUSTIFOLIA LEAF  
ASCOPHYLLUM NODOSUM  
TAGETES ERECTA FLOWER  
STEARYL ALCOHOL  
METHYLISOTHIAZOLINONE  
MENTHOL  
EUCALYPTUS GLOBULUS LEAF  
GLYCERYL MONOSTEARATE  
OLIVE OIL  
POLYOXYL 40 HYDROGENATED CASTOR OIL  
AZADIRACHTA INDICA SEED OIL  
ISOPROPYL ALCOHOL  
MELALEUCA ALTERNIFOLIA LEAF  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60608-013-00 56.69 g in 1 BOTTLE, PUMP None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 06/02/2011

Labeler - BioChemics, Inc. (802946426)
Establishment
Name Address ID/FEI Operations
Coastal Products Company 782445688 manufacture

Revised: 06/2011 BioChemics, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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