Biotin H3 Anti-Dandruff Curly Hair: Package Insert and Label Information

BIOTIN H3 ANTI-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.

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 Curly
(click image for full-size original)
BIOTIN H3 ANTI-DANDRUFF CURLY HAIR
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73388-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PEG-120 METHYL GLUCOSE DIOLEATE
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)
EDETATE SODIUM (EDETIC ACID)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
GLYCERIN
SODIUM HYDROXIDE
WATER
SODIUM LAURETH SULFATE
COCAMIDOPROPYL BETAINE
SODIUM LAUROYL SARCOSINATE
COCO MONOETHANOLAMIDE
DIMETHICONOL (100000 CST)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)
TRIETHANOLAMINE DODECYLBENZENESULFONATE
METHYLISOTHIAZOLINONE
CITRIC ACID MONOHYDRATE
DMDM HYDANTOIN
METHYLCHLOROISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73388-103-12 355 mL in 1 BOTTLE, PLASTIC None
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)

Revised: 01/2020 Salones de Belleza y Equipos de El Salvador Sociedad Anonima de Capital Variable

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.