H PLUS HOLDINGS NOURISHING- hydrocortisone acetate shampoo
Prime Enterprises, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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H Plus 1.0% Hydrocortisone Nourishing Shampoo

Active Ingredients

Hydrocortisone acetate 1%

Purpose

Antipuritic (Anti-Itch)

Uses

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

Warnings

For external use only.

Avoid contact wih the eyes.

If contact occurs, rinse eyes thoroughly with water.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help or contact a Posion 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. Children under 2 years of age: do not use, consult a doctor. Store at room temperature.

Inactive Ingredients

Hair Sanity Anti-Itch Shampoo Step 1

Principle Display Label

H PLUS HOLDINGS NOURISHING
hydrocortisone acetate shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0411
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WILLOW BARK (UNII: S883J9JDYX)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)
ALLANTOIN (UNII: 344S277G0Z)
RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
LACTIC ACID (UNII: 33X04XA5AT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ISOMALT (UNII: S870P55O2W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL STEARATE (UNII: 0324G66D0E)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	white (White Pearl)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0411-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/12/2019

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(58443-0411) , label(58443-0411) , analysis(58443-0411) , pack(58443-0411)

Revised: 8/2021

Document Id: ca6804e4-8982-4004-e053-2995a90a7508

Set id: ca62e47e-8cba-e9e1-e053-2a95a90abffb

Version: 2

Effective Time: 20210825

Prime Enterprises, Inc.