AFFIRMCARE SCALP THERAPY ANTI-DANDRUFF EXFOLIATING MASQUE- pyrithione zinc lotion

AffirmCare Scalp Therapy by

Drug Labeling and Warnings

AffirmCare Scalp Therapy by is a Otc medication manufactured, distributed, or labeled by Avlon Industries, Inc., Avlon Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Pyrithione 1%

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis

Uses

For the relief of scalp flaking, itching and irritation associated with dandruff and seborrheic dermatitis.

Warnings

• For external use only.

ASK DOCTOR

Ask a doctor before use if you have a condition that covers a large area of the body.

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 with regular use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For best results, use at least twice a week, or as directed by a doctor.
• Shake well before use.
• Apply after rinsing Scalp Therapy Hydrating Anti-Dandruff Shampoo by gently massaging into hair and scalp. Rinse well.

Inactive Ingredient

Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Betaine, Cetearyl Alcohol, Cocos
Nucifera (Coconut) Oil, Cetyl Alcohol, Juglans Regia (Walnut) Shell Powder, Glycerin,
Behentrimonium Chloride, Stearamidopropyl Dimethylamine, Phytosterols,
Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Melia
Azadirachta Seed Oil, Origanum Vulgare Leaf Extract, Nigella Sativa Seed Oil, Linum
Usitatissimum (Linseed) Seed Extract, Camellia Sinensis Leaf Extract, Menthol,
Keratin, Hydrolyzed Keratin, Piroctone Olamine, Panthenol, Polyquaternium-37,
PPG-1 Trideceth-6, Phenoxyethanol, Caprylyl Glycol, Caprylic Acid, Fragrance/Parfum,
Citric Acid, Isostearyl Ethylimidazolinium Ethosulfate, Polyacrylamide, Propylene
Glycol Dicaprylate/Dicaprate, Dipropylene Glycol, Amyl Cinnamal, Benzyl Benzoate,
Limonene, Hexyl Cinnamal.

QUESTIONS

Questions or comments?1-800-332-8566

PRINCIPAL DISPLAY PANEL

AffirmCare Scalp Therapy
Anti-Dandruff Exfoliating Masque (8 oz & 32 oz)

Product NDC# 63766-302

INGREDIENTS AND APPEARANCE

AFFIRMCARE SCALP THERAPY  ANTI-DANDRUFF EXFOLIATING MASQUE
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63766-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT OIL (UNII: Q9L0O73W7L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BETAINE (UNII: 3SCV180C9W)
GLYCERIN (UNII: PDC6A3C0OX)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
LINSEED OIL (UNII: 84XB4DV00W)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)
CAPRYLIC ACID (UNII: OBL58JN025)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
MENTHOL (UNII: L7T10EIP3A)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
OREGANO (UNII: 0E5AT8T16U)
BENZYL BENZOATE (UNII: N863NB338G)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)
HYDROLYZED SHEEP WOOL KERATIN (2000 MW) (UNII: NZR037QF7Z)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
ISOSTEARYL ETHYLIMIDAZOLINIUM ETHOSULFATE (UNII: MZE1E3A2ZS)
JUGLANS REGIA WHOLE (UNII: 87EJ76IO83)
PANTHENOL (UNII: WV9CM0O67Z)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63766-302-01	227 g in 1 JAR; Type 0: Not a Combination Product	09/13/2018
2	NDC: 63766-302-02	907 g in 1 JAR; Type 0: Not a Combination Product	09/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/13/2018

Labeler - Avlon Industries, Inc. (121278626)

Establishment
Name	Address	ID/FEI	Business Operations
Avlon Industries Inc		121278626	manufacture(63766-302)