ANTI HAIR LOSS- pyrithione zinc, biotin soap 
Golden B America, LLC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Anti Hair Loss Soap

Active ingredients

Zinc pyrithione (2.1%)

Biotin (0.06%)

Purpose

Anti-dandruff

Anti-hairloss

Uses

Helps prevent hair loss and strengthen hair root and thicken hair. Helps to treat symptoms caused by dandruff

Warnings

For external use only

Do not use when scalp is red, inflamed, irritated, or painful

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

1. Wet soap to generate foam to cover desired part of scalp.

2. Massage foam well into the hair and scalp by rubbing gently.

3. Thoroughly massage 3-5 min to generate more soap then rinse.

4. If hair is dry and stiff after wash use conditioner and rinse.

5. Repeat 2-3 times daily as needed.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Inactive ingredients

Nicotinamide, Zinc Oxide, Shea Butter, Chamomile Extract, Arginine, Grape Seed Oil, Tea Tree Oil, Aloe Extract, Gardenia Seed Extract, Green Tea Extract, Mugwort Extract, Licorice Root Extract, Shrubby Sophora Extract, morus alba bark extract, Tocophenol, Dexpanthenol, Sekken Soji, Charcoal

Anti Hair Loss Soap

anti hair loss soap

ANTI HAIR LOSS 
pyrithione zinc, biotin soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72100-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.1 g  in 100 g
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.06 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
CHAMOMILE (UNII: FGL3685T2X)  
ARGININE (UNII: 94ZLA3W45F)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
TEA TREE OIL (UNII: VIF565UC2G)  
ALOE (UNII: V5VD430YW9)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
LICORICE (UNII: 61ZBX54883)  
MORUS ALBA BARK (UNII: 7O71A48NDP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72100-100-021 in 1 PACKAGE03/13/2018
1NDC:72100-100-01100 g in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/13/2018
Labeler - Golden B America, LLC. (081015296)
Registrant - Golden B America, LLC. (081015296)
Establishment
NameAddressID/FEIBusiness Operations
Golden B America, LLC.081015296relabel(72100-100)
Establishment
NameAddressID/FEIBusiness Operations
Asan C&s631139649manufacture(72100-100)

Revised: 3/2018
Document Id: 6664713c-8bd2-38c4-e053-2991aa0a7772
Set id: 6664713c-8bd1-38c4-e053-2991aa0a7772
Version: 4
Effective Time: 20180301
 
Golden B America, LLC.