Active Ingredients

Hydrocortisone acetate 0.5%

Purpose

Antipruritic (Anti-Itch)

Uses

for the temporary relief of itching associated with minor skin irritations and rashes.

Warnings

For external use only.

Avoid contact with the eyes.

If conditions worsens or if symptoms persist, stop use of this product and consult a doctor.

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

Directions

Apply a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. Add additional water and cleanser for increased lather. Massage lather into scalp and rinse thoroughly with warm water. Use daily or minimum of 3 times per week.

Water, Sodium Lauroyl Methyl Isethionate, Acrylates Copolymer, Decyl Glucoside, Sodium Lauroamphoacetate, Sodium Methyl Cocoyl Taurate, Sodium Cocoyl Isethionate, Butylene Glycol, Glycereth-26, Cocamidopropyl Betaine, Fragrance, Glycerin, Glycol Stearate, Phenoxyethanol, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Allantoin, BHT, Disodium EDTA, Ethylhexylglycerin, Caprylic/Capric Triglyceride, Methylpropanediol, 4-Terpineol, Isomalt, Rhododendron Ferrugineum Leaf Cell Culture Extract, Lecithin, Lactic Acid, Salicylic Acid, Sea Whip Extract, Salix Alba (Willow) Bark Extract

Hair Sanity Part I

Principal Display Image

HAIR SANITY HAIR SANITY PART I
hydrocortisone acetate lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0246
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SALIX ALBA BARK (UNII: 205MXS71H7)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL STEARATE (UNII: 0324G66D0E)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
ISOMALT (UNII: S870P55O2W)
RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
4-TERPINEOL, (+)- (UNII: HZK34LN80N)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0246-4	237 mL in 1 TUBE; Type 0: Not a Combination Product	04/18/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/18/2017

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	pack(58443-0246) , manufacture(58443-0246) , label(58443-0246) , analysis(58443-0246)