DERMAHARMONY PYRITHIONE ZINC WITH SHEA BUTTER- pyrithione zinc soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)

Available from:

D3 Development, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Dandruff, Seborrheic dermatitis soap Uses Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

Authorization status:

OTC monograph final

Summary of Product characteristics

DERMAHARMONY PYRITHIONE ZINC WITH SHEA BUTTER- PYRITHIONE ZINC SOAP
D3 DEVELOPMENT, 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._
----------
2% PYRITHIONE ZINC BAR WITH SHEA BUTTER
_DRUG FACTS_
_ACTIVE INGREDIENT_
Pyrithione zinc 2%
_PURPOSE_
Dandruff, Seborrheic dermatitis soap
_USES_
Controls and reduces the symptoms of dandruff and seborrheic
dermatitis.
_WARNINGS_
FOR EXTERNAL USE ONLY
ASK A DOCTOR BEFORE USE IF YOU HAVE a condition that covers a large
area of the
body.
WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs,
rinse eyes
thoroughly with water.
STOP USE AND ASK A DOCTOR IF condition worsens or does not improve
after regular
use as directed.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away.
_DIRECTIONS_
Use on affected areas in place of your regular soap
For best results use at least twice a week or as directed by a doctor
Work up a lather using warm water and massage into affected areas
Rinse well
_OTHER INFORMATION_
Store at room temperature
Lot number and expiration date are printed on back panel.
_INACTIVE INGREDIENTS_
Sodium palmate, shea butter, sodium cocoate*, sodium palm kernelate*,
glycerin, water,
cocoa butter, titanium dioxide, Avena Sativa (oat) kernel flour,
tetrasodium glutamate
diacetate, tocopheryl acetate (vitamin E), Rosmarinus officinalis
(rosemary) leaf extract.
*May contain this ingredient
_QUESTIONS?_
1-800-827-3730
www.dermaharmony.com
Distributed by:
D3 Development, Inc., Portland, ME 04101
Made in the USA
dermaharmony
2% PYRITHIONE ZINC SOAP WITH SHEA BUTTER
For Seborrheic Dermatitis & Dandruff
NET WT 3.7 OZ (105 G)
DERMAHARMONY PYRITHIONE ZINC WITH SHEA BUTTER
pyrithione zinc soap
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:71819-017
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT