BIOTIN H3 ANTI-DANDRUFF STRAIGHT- 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 Straight Hair

Drug Facts

Active Ingredient

Active ingredientPurpose
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

2 In 1 Shampoo & Conditioner/ Shampoo y Acondicionador 2 en 1

UltraZinc

Anti-Dandruff/Control Caspa

Pyrithione Zinc 1%

12 oz (355 mL)

Straight Hair/Cabello Liso

Straight

BIOTIN H3 ANTI-DANDRUFF STRAIGHT 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73388-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73388-101-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/09/2019
Labeler - Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable (851242271)

Revised: 1/2021
Document Id: b8e95b54-e430-11e7-e053-2995a90a57ce
Set id: 9b0277b1-b564-b2db-e053-2995a90aa194
Version: 2
Effective Time: 20210114
 
Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable