Biotin H3 Anti-Dandruff Shampoo Curly

Biotin H3 2in1 Dandruff Curly Hair by

Drug Labeling and Warnings

Biotin H3 2in1 Dandruff Curly Hair 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]

BIOTIN H3 2IN1 DANDRUFF CURLY HAIR- pyrithione zinc shampoo 
Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable

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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Biotin H3 Anti-Dandruff Shampoo Curly

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)

Curly Hair/Cabello Rizo

BIOTIN H3 2IN1 DANDRUFF CURLY HAIR 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73388-100
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: 73388-100-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2019	01/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/09/2019	01/06/2020

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

Revised: 1/2020

Document Id: 9b7b2f74-8414-3fa3-e053-2995a90a348f

34390-5

Set id: 94861722-ad19-5721-e053-2a95a90a1a32

Version: 2

Effective Time: 20200106

 

Salones de Belleza y Equipos de El Salva