HAIRSANITY STEP 1- hydrocortisone acetate shampoo 
H Plus Holdings

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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HairSanity™ Step 1

Drug Facts

Active ingredient

Hydrocortisone acetate 0.5%

Purpose

Antipruritic

Uses

Warnings

For external use only.

Avoid contact with the eyes.

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. 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. Children under 2 years of age: do not use, consult a doctor. Store at room temperature.

Inactive ingredients

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, Menthol, Benzyl Alcohol, Isopropyl Palmitate, Polyglyceryl-4 Laurate, Poloxamer 407, Citric Acid

PRINCIPAL DISPLAY PANEL - 89 mL Tube Label

HAIR
SANITY

STEP 1

REGULAR USE OF
OUR 2 STEP SYSTEM
WILL CHANGE THE
WAY YOUR HAIR
LOOKS AND FEELS
FOREVER.

ANTI-ITCH SHAMPOO
for beautiful, more manageable,
and softer hair.
Hydrocortisone Acetate

3 FL OZ (89 mL)

Principal Display Panel - 89 mL Tube Label
HAIRSANITY STEP 1 
hydrocortisone acetate shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71605-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERETH-26 (UNII: NNE56F2N14)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
4-TERPINEOL, (+)- (UNII: HZK34LN80N)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
ISOMALT (UNII: S870P55O2W)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71605-000-01237 mL in 1 TUBE; Type 0: Not a Combination Product08/10/2017
2NDC:71605-000-0489 mL in 1 TUBE; Type 0: Not a Combination Product08/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/10/2017
Labeler - H Plus Holdings (080731249)

Revised: 7/2017
Document Id: 48e7b70c-97f4-410d-a299-36ca109a9d71
Set id: 6d72f278-d15b-473e-a0d1-9f483b4c2201
Version: 1
Effective Time: 20170726
 
H Plus Holdings