H PLUS HOLDINGS NOURISHING- salicylic acid rinse 
Prime Enterprises

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 1.85% Salicylic Acid Anti-Dandruff Conditioner 3 Fl. Oz.

Active Ingredients

Salicylic Acid 1.85%

Purpose

Anti-Dandruff

Uses

helps prevent reoccurance of flaking and itching associated with dandruff.

Warnings

For external use only.

Avoid contact wih the eyes. If contact occurs, rinse eyes thoroughly with water.

If condition worsens, or does not improve after regular use of this product as directed, stop use of this product and consult 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

Gently massage into scalp and work through hair to the ends. Leave on 30 seconds for normal hair and 2-3 minutes for damaged and/or processed hair. Rinse with warm water, dry and style as usual. For best results use at least twice a week or as directed by a doctor. Store at room temperature.

Inactive Ingredients

Water, Cetyl Alcohol, Stearyl Alcohol, Glycereth-26, Bis-Cetearyl Amodimethicone, Dicetyldimonium Chloride, Behentrimonium Chloride, Butylene Glycol, Glycerin, Dimethicone, Distearyldimonium Chloride, Fragrance, Guar Hydroxypropyltrimonium Chloride, Phenoxyethanol, Isopropyl Alcohol, Sodium Hydroxide, Alcohol Denat., Caprylic/Capric Triglyceride, Tocopheryl Acetate, Allantoin, Dipropylene Glycol, Polysilicone-19, Ethylhexylglycerin, Methylpropanediol, Avena Sativa (Oat) Kernel Extract, 4-Terpineol, Lecithin, Isopropyl Palmitate, Poloxamer 407, Isomalt, Algae Extract, Salix Alba (Willow) Bark Extract, Sea Whip Extract, Polyglyceryl-4 Laurate, Menthol, Benzyl Alcohol, Laminaria Digitata Extract, Rhododendron Ferrugineum Leaf Cell Culture Extract

H Plus 1.85% Salicylic Acid Anti-Dandruff Conditioner 3 Fl. Oz.

Principle Display Label

H PLUS HOLDINGS  NOURISHING
salicylic acid rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0247
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID18.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOMALT (UNII: S870P55O2W)  
ALCOHOL (UNII: 3K9958V90M)  
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
OAT (UNII: Z6J799EAJK)  
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WILLOW BARK (UNII: S883J9JDYX)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERETH-26 (UNII: NNE56F2N14)  
GLYCERIN (UNII: PDC6A3C0OX)  
RHODODENDRON FERRUGINEUM LEAF (UNII: 30NOV1XI0P)  
4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)  
ALLANTOIN (UNII: 344S277G0Z)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0247-389 mL in 1 TUBE; Type 0: Not a Combination Product06/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/13/2019
Labeler - Prime Enterprises (101946028)
Registrant - Prime Enterprises (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028manufacture(58443-0247) , label(58443-0247) , analysis(58443-0247) , pack(58443-0247)

Revised: 10/2021
Document Id: cf6c6211-c343-ba38-e053-2995a90a8758
Set id: cf6c5838-37b6-1b68-e053-2995a90a7e4e
Version: 1
Effective Time: 20211028
 
Prime Enterprises