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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0411
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White Pearl) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0411-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/12/2019
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(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.