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Name:Antidandruff Medicated
Manufacturer:Safeway Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts Box - Back Label

ANTIDANDRUFF  MEDICATED - selenium sulfide shampoo 
SAFEWAY 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 Box - Back Label

ACTIVE INGREDIENT

SELENIUM SULFIDE 1% (ANTI DANDRUFF)


USES AND DIRECTIONS

  • USES: FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURRENCE.
  • DIRECTIONS:SHAKE WELL, SHAMPOO, THEN RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

WARNINGS

  • FOR EXTERNAL USE ONLY.

ASK A DOCTOR BEFORE USING IF YOU HAVE

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR-TREATED OR PERMED HAIR, RINSE THOROUGHLY.

STOP USE AND ASK A DOCTOR IF

  • CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.

KEEP OUT OF REACH OF CHILDREN

  • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

PACKAGE FRONT AND BACK LABELS

11OZ FRONT AND BACK LABELS: ../images_otc/antidandruff_safeway11.jpg11 OZ FRONT AND BACK LABELS

QUESTIONS/COMMENTS?

1 - 888 - SAFEWAY


ANTIDANDRUFF   MEDICATED
selenium sulfide shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-610
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELENIUM SULFIDE (SELENIUM ) SELENIUM SULFIDE 1.0000 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21130-610-11 325 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358 08/05/2010

Labeler - SAFEWAY INC (009137209)

Revised: 08/2010 SAFEWAY INC



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


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