CREMO ANTI-DANDRUFF FRESH BLEND- pyrithione zinc shampoo

Cremo Anti-Dandruff Fresh blend by

Drug Labeling and Warnings

Cremo Anti-Dandruff Fresh blend by is a Otc medication manufactured, distributed, or labeled by Cremo company, RNA PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Pyrithione Zinc 1% Anti-Dandruff

PURPOSE

Use Help prevent reccurence of flaking and itching associated with dandruff

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Posion Control Center immediately.

INDICATIONS & USAGE

• Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

WARNINGS

Warnings

• FOR EXTERNAL USE ONLY
• When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

DOSAGE & ADMINISTRATION

Directions

• For best results, use at least twice a week, or as directed by a doctor
• Wet hair, massage onto scalp and rinse
• repeat if desired

INACTIVE INGREDIENT

Inactive ingredients

Water(aqua, Eau), Sodium Laureth Sulfate, Disodium Cocoamphodiacetate, Acrylates Copolymer, Glycerin, Cocamidopropyl Betaine, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, glycereth-2 Cocoate, Fragrance, Citric Acid.

PRINCIPAL DISPLAY PANEL

Cremo

Anti-Dandruff Shampoo

Itch & Flake Relief Formula

Moisturizes Hair and scalp while relieving dryness and itch

Fresh Blend

16 fl oz 473 mL

INGREDIENTS AND APPEARANCE

CREMO ANTI-DANDRUFF FRESH BLEND 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71825-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
WATER (UNII: 059QF0KO0R)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71825-104-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/11/2019

Labeler - Cremo company (078708508)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARMA		079103999	manufacture(71825-104)