BIOTIN H3 ANTI-DANDRUFF NORMAL- pyrithione zinc shampoo

Biotin H3 Anti-Dandruff Normal by

Drug Labeling and Warnings

Biotin H3 Anti-Dandruff Normal by is a Otc medication manufactured, distributed, or labeled by Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

• Active ingredient: Purpose
• Pyrithione Zinc 1% ……………………………………….: Anti-dandruff

Uses

Controls and helps eliminate the symptoms of dandruff asoiciated with

• itching
• irritation
• redness
• flaking

Warnings

For external uses only. Avoid contact with the eyes. If conctact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product.

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hair, massage BIOTIN H3 Shampoo onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor

Inactive Ingredient

Water, Sodium Laureth Sulfate, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Acrylates Copolymer, Cocamide MEA, Dimethiconol (and) TEA-Dodecylbenzenesulfonate, Glycerin, Tetrasodium EDTA, DMDM Hydantoin (and) Methylchloroisothiazolinone (and) Methylisothiazolinone, Citric Acid, PEG-120 Methyl Glucose Dioleate, Fragrance, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Polyquaternium -7

Questions or comments?

+1-302-628-4178 (M-F) 8 AM-5PM EST or www.sabesa.com.sv

Prinicipal Display Panel

New/Nuevo

Biotin H3

UltraZinc

Anti-Dandruff/Control Caspa

Pyrithione Zinc 1%

12 oz (355 mL)

Normal Hair/Cabello Normal

INGREDIENTS AND APPEARANCE

BIOTIN H3 ANTI-DANDRUFF NORMAL 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73388-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
EDETATE SODIUM (UNII: MP1J8420LU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73388-102-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/09/2019

Labeler - Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable (851242271)