H Plus Holdings Nourishing: Package Insert and Label Information

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.

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 8 Fl. Oz.

Principle Display Label
(click image for full-size original)

H PLUS HOLDINGS NOURISHING
salicylic acid rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0249
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 17.575 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DICETYLDIMONIUM CHLORIDE
ISOMALT
ALCOHOL
BEHENTRIMONIUM CHLORIDE
STEARYL ALCOHOL
OAT
PHYMATOLITHON CALCAREUM
ISOPROPYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
DIMETHICONE
BENZYL ALCOHOL
ISOPROPYL PALMITATE
MENTHOL
WATER
BUTYLENE GLYCOL
LECITHIN, SOYBEAN
POLOXAMER 407
WILLOW BARK
PSEUDOPTEROGORGIA ELISABETHAE
ETHYLHEXYLGLYCERIN
GLYCERETH-26
GLYCERIN
RHODODENDRON FERRUGINEUM LEAF
4-TERPINEOL, (+/-)-
ALLANTOIN
METHYLPROPANEDIOL
PHENOXYETHANOL
SODIUM HYDROXIDE
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
MEDIUM-CHAIN TRIGLYCERIDES
DIPROPYLENE GLYCOL
LAMINARIA DIGITATA
CETYL ALCOHOL
DISTEARYLDIMONIUM CHLORIDE
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58443-0249-4 237 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 06/13/2019
Labeler — Prime Enterprises (101946028)
Registrant — Prime Enterprises (101946028)
Establishment
Name Address ID/FEI Operations
Prime Enterprises 101946028 manufacture (58443-0249), label (58443-0249), analysis (58443-0249), pack (58443-0249)

Revised: 10/2021 Prime Enterprises

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