HEB DANDRUFF- selenium sulfide shampoo

HEB Dandruff by

Drug Labeling and Warnings

HEB Dandruff by is a Otc medication manufactured, distributed, or labeled by H E B, Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SELENIUM SULFIDE  ONE PERCENT

PURPOSE

ANTI DANDRUFF

USES

For relief of flaking, and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of reoccurence

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 EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.  FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY.

STOP USING THIS PRODUCT 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

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

SHAKE WELL, APPLY A SHAMPOO, RINSE THOROUGHLY.  FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

INACTIVE INGREDIENTS

WATER, AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, ACRYLATES COPOLYMER, AMMONIUM XYLENESULFONATE, FRAGRANCE, DIMETHICONE, CETYL ALCOHOL, SODIUM BENZOATE, CITRIC ACID, SODIUM HYDROXIDE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, SODIUM CITRATE, RED 4 (CI 14700).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEB DANDRUFF  
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-613
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B)	SELENIUM SULFIDE	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
CARBOMER 934 (UNII: Z135WT9208)
3-HYDROXY-4-METHOXYBENZENESULFONIC ACID (UNII: 05L0075KBX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-613-14	420 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/08/2011

Labeler - H E B (007924756)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture