RAPHE PHARMACEUTIQUE PRO VITAMIN B5 BIOTIN- pyrithione zinc liquid

RAPHE PHARMACEUTIQUE PRO VITAMIN B5 BIOTIN by

Drug Labeling and Warnings

RAPHE PHARMACEUTIQUE PRO VITAMIN B5 BIOTIN by is a Otc medication manufactured, distributed, or labeled by AmWiner & Raphe Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Pyrithione Zinc

Purpose

Seborrheic dermatitis

Uses

Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis.
Helps eliminate recurrence of seborrheic dermatitis

Warnings

For external use only
Ask a doctor before use if condition covers a large area.
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.
Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Directions

Apply to affected area one ml two times daily or as directed by the physician

Inactive ingredients

Purified Water, Propylene Glycol, Vitamin B5, Minoxidil, Green Tea, Biotin, Saw Palmetto, Finasteride.

Other information

Store at 59° to 77°F (15° to 25°C)

Product label

INGREDIENTS AND APPEARANCE

RAPHE PHARMACEUTIQUE PRO VITAMIN B5 BIOTIN 
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82627-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PANTHENOL (UNII: WV9CM0O67Z)
MINOXIDIL (UNII: 5965120SH1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BIOTIN (UNII: 6SO6U10H04)
FINASTERIDE (UNII: 57GNO57U7G)
SAW PALMETTO (UNII: J7WWH9M8QS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82627-002-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/01/2022

Labeler - AmWiner & Raphe Holdings LLC (113433590)

Establishment
Name	Address	ID/FEI	Business Operations
AmWiner & Raphe Holdings LLC		113433590	manufacture(82627-002)