ANTI HAIR LOSS- pyrithione zinc, biotin soap

Anti Hair Loss by

Drug Labeling and Warnings

Anti Hair Loss by is a Otc medication manufactured, distributed, or labeled by Golden B America, LLC., Asan C&s. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
• do not apply directly to wound or open cut

Stop use and ask a doctor if

• rash or irritation on scalp in develops and lasts
• condition does not improve or worsen after regular use of this product as directed

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

INGREDIENTS AND APPEARANCE

ANTI HAIR LOSS 
pyrithione zinc, biotin soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72100-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2.1 g  in 100 g
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	0.06 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72100-100-02	1 in 1 PACKAGE	03/13/2018
1	NDC: 72100-100-01	100 g in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/13/2018

Labeler - Golden B America, LLC. (081015296)

Registrant - Golden B America, LLC. (081015296)

Establishment
Name	Address	ID/FEI	Business Operations
Golden B America, LLC.		081015296	relabel(72100-100)

Establishment
Name	Address	ID/FEI	Business Operations
Asan C&s		631139649	manufacture(72100-100)