ANTI DANDRUFF- keranique anti dandruff shampoo lotion 
Profectus Beauty, 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 3.0%

Uses

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis, Anti-Psoriasis

Warnings

Because we utilize as many naturally derived ingredients as
possible, our products may vary in color over time and with each new batch
we make. These natural variations do not in any way affect the quality of
efficacy of the product.
█ For external use only. █ Ask a doctor before use if you have a condition
that covers a large area of the body █ Avoid contact with eyes. If contact
occurs, rinse eyes thoroughly with water. █ Stop use and ask a doctor if the
condition worsens or does not improve after regular use of this product as
directed. 

Keep out of reach of children.

█ Keep out of the reach of children. If swallowed, get medical help
or contact the Poison Control Center right away.

Directions

█ For best results use at least twice a week or as directed by a doctor.
█ For maximum dandruff control, use every time you shampoo.
█ Shake before use, wet hair, massage onto scalp, leave on scalp for
several minutes, rinse, repeat if desired.

Other Information

Store in a cool, dry place

Inactive Ingredients

Water (Aqua), Sodium Coco-Sulfate,
Cocamidopropyl Betaine, Glycerin, Aloe Barbadensis Leaf Juice, Fragrance,
Decyl Glucoside, Camellia Sinensis Leaf Extract, Hydrolyzed Quinoa,
Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet
Almond) Oil, Xylitol, Hydrolyzed Soy Protein, Triethyl Citrate, Gluconolactone,
Polyquaternium-7, Phenoxyethanol, Benzyl Alcohol, Sodium Benzoate,
Potassium Sorbate.

Questions or Comments?

Call toll free 1-888-237-4131 or visit www.keranique.com

Principal Display Panel

70550-329

ANTI DANDRUFF 
keranique anti dandruff shampoo lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70550-329
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCINE (UNII: TE7660XO1C)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82)  
PRUNUS DULCIS WHOLE (UNII: X3EC86GF0Z)  
XYLITOL (UNII: VCQ006KQ1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70550-329-011 in 1 CARTON11/06/2022
1240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/06/2022
Labeler - Profectus Beauty, LLC (118310694)

Revised: 11/2022
Document Id: ecd389e1-213e-24bc-e053-2a95a90ad556
Set id: 6ce5f0d0-efbb-4a6a-a813-544586b16f72
Version: 2
Effective Time: 20221106
 
Profectus Beauty, LLC