Oribe Serene Scalp Anti Dandruff by Oribe Hair Care LLC DRUG FACTS

Drug Details [pdf]

ORIBE SERENE SCALP ANTI DANDRUFF- oribe serene scalp anti dandruff lotion
Oribe Hair Care LLC

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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DRUG FACTS

Active Ingredients

Salicylic Acid 2.0%

Uses

For the relief of the symptoms of dandruff

Purpose

Dandruff Shampoo

Warnings

For external use only

When using this product

Avoid contact wilh lhe eyes.
lf conlacl occurs, rinse thoroughly wlth water

Keep out of reach of children.

lf condition worsens or does nol improve alter regular use of this product as directed, consult a doctor.

Directions

For best resulls use ot least twice a week or as directed by a doctor

Other Information

Protect lhis product from excessive heat and direct sun.

Inactive Ingredients

Aqua/Water/Eau, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerin, Acrylates Copolymer, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Citrullus Lanatus (Watermelon) Fruit Extract, Litchi Chinensis Fruit Extract, Leontopodium Alpinum Extract, Biotin, Niacinamide, Panthenol, Tocopheryl Acetate, Vaccinium Myrtillus Fruit Extract, Saccharum Officinarum (Sugarcane) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Acer Saccharum (Sugar Maple) Extract, Acacia Seyal Gum Extract, Pisum Sativum (Pea) Sprout Extract, Hydrolyzed Quinoa, Hydrolyzed Vegetable Protein PG-Propyl Silanetriol, Ascorbic Acid, Aspartic Acid, Alanine, Arginine, Glycine, Histidine, Isoleucine, Phenylalanine, Proline, Serine, Threonine, Valine, Sodium PCA, PCA, Capryloyl/Caproyl Methyl Glucamide, Polysorbate 20, PEG-8 Laurate, Potassium Hydroxide, Guar Hydroxypropyltrimonium Chloride, Bis-Cetearyl Amodimethicone, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Silicone Quaternium-22, Cetyl Triethylmonium Dimethicone PEG-8 Succinate, Laureth-4, Polyglyceryl-3 Caprate, Quaternium-95, PEG/PPG-18/18 Dimethicone, Ceteareth-25, Ceteareth-7, Sodium Lactate, Dipropylene Glycol, Propanediol, Tetrasodium EDTA, Synthetic Fluorphlogopite, Tin Oxide, Citric Acid, Potassium Sorbate, Sodium Benzoate, Chlorphenesin, Phenoxyethanol, Parfum/Fragrance, Hexyl Cinnamal, Limonene, Linalool, CI 77891 (Titanium Dioxide)

Questions or Comments?

1-888-0RIBE-99 / info@oribe.com

Principal Display Panel

71438

ORIBE SERENE SCALP ANTI DANDRUFF
oribe serene scalp anti dandruff lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71438-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
VALINE (UNII: HG18B9YRS7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-8 LAURATE (UNII: 762O8IWA10)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
LAURETH-4 (UNII: 6HQ855798J)
QUATERNIUM-91 (UNII: 00J8H295NB)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
CITRULLUS LANATUS VAR. LANATUS WHOLE (UNII: 3J5I6254YO)
LITCHI CHINENSIS WHOLE (UNII: 47EV26G96N)
LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM)
BIOTIN (UNII: 6SO6U10H04)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
VACCINIUM MYRTILLUS WHOLE (UNII: EE76EZ4QNZ)
SACCHARUM OFFICINARUM WHOLE (UNII: 3Z20C92XNB)
ACACIA SENEGAL WHOLE (UNII: QP4QYZ033C)
PISUM SATIVUM WHOLE (UNII: J21YE3W98E)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASPARTIC ACID (UNII: 30KYC7MIAI)
ALANINE (UNII: OF5P57N2ZX)
ARGININE (UNII: 94ZLA3W45F)
GLYCINE (UNII: TE7660XO1C)
HISTIDINE (UNII: 4QD397987E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 71438-010-20	1 in 1 CARTON	10/05/2022
1		1000 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	10/05/2022

Labeler - Oribe Hair Care LLC (008843347)

Registrant - Oribe Hair Care LLC (008843347)

Revised: 10/2022

Document Id: ea4ca1f1-3e3a-926d-e053-2a95a90abb42

Set id: abaf1c64-1c4d-481a-9872-b64fcf82cc63

Version: 1

Effective Time: 20221005