MAXXAM DERMACARE PRE-SHAMPOO SCALP TREATMENT- pyrithione zinc shampoo shampoo

maxxam dermaCare Pre-Shampoo Scalp Treatment by

Drug Labeling and Warnings

maxxam dermaCare Pre-Shampoo Scalp Treatment by is a Otc medication manufactured, distributed, or labeled by EI GLOBAL GROUP LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Pyrithione Zinc 1.8%

INACTIVE INGREDIENT

Water (Aqua), Cocamidopropyl Hydroxysultaine, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Glutamate, Sodium Methyl Cocoyl Taurate, Zinc Pyrithione, Cocamide MIPA, Glycol Distearate , Decyl Glucoside , Glycerin, Silk Amino Acids, Acrylates Copolymer , Aloe Barbadensis Leaf Extract, Hydroxypropyltrimonium Hydrolyzed Wheat Protein, Chamomilla Recutita (Matricaria) Flower Extract, PEG-150 Pentaerythrityl Tetrastearate, Guar Hydroxypropyltrimonium Chloride, Divinyldimethicone/ Dimethicone Copolymer, Polyquatemium-10, Pro+N2pylene Glycol, Cocodimonium Hydroxypropyl Hydrolyzed Hair Keratin, Phenoxyethanol, Fragrance (Partum), Allantoin, Tetrasodium EDTA, Ctlric Acid, PEG-7 Glyceryl Cocoate, Amodimethicone, Panthenol, Cetrimonium Chloride, Camellia Sinensis Seed Oil, Methylchloroisothiazolinone, Methylisothiazolinone​

DOSAGE & ADMINISTRATION

Use: Anti-dandruff

Directions: Use once or twice a week on your scalp, beneath your head of hair only. Squeeze a 1/8 oz. of shampoo into your palm (size of half dollar). Massage into scalp. Leave on scalp for 1-2 minutes then rinse thoroughly. Maxxam DermaCare is for the scalp only; it is not intended to cleanse your head of hair. After treatment, use your regular Maxxam Shampoo and Conditioner to cleanse and hydrate your head of hair.

INDICATIONS & USAGE

Use: Anti-dandruff

Directions: Use once or twice a week on your scalp, beneath your head of hair only. Squeeze a 1/8 oz. of shampoo into your palm (size of half dollar). Massage into scalp. Leave on scalp for 1-2 minutes then rinse thoroughly. Maxxam DermaCare is for the scalp only; it is not intended to cleanse your head of hair. After treatment, use your regular Maxxam Shampoo and Conditioner to cleanse and hydrate your head of hair.

WARNINGS

WARNINGS

• For external use only
• 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 this product as direct.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

PURPOSE

Anti-dandruff

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXXAM DERMACARE PRE-SHAMPOO SCALP TREATMENT 
pyrithione zinc shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71203-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMOMILE (UNII: FGL3685T2X)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE SODIUM (UNII: MP1J8420LU)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN (UNII: 344S277G0Z)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71203-006-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/19/2018

Labeler - EI GLOBAL GROUP LLC (809220911)

Registrant - EI GLOBAL GROUP LLC (809220911)