DS-526-1 ELEVATE Anti-Dandruff Shampoo

Elevate Anti Dandruff by

Drug Labeling and Warnings

Elevate Anti Dandruff by is a Otc medication manufactured, distributed, or labeled by Foshan Yilai Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELEVATE ANTI DANDRUFF- elevate anti dandruff shampoo shampoo 
Foshan Yilai Cosmetics Co., Ltd.

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DS-526-1 ELEVATE Anti-Dandruff Shampoo

Ketococonazole 1%

Anti dandruff shampoo

Do not use
on scalp that is broken or inflamed
If you are allergic to ingredients in this product

When using this product
avoid contact with eyes
If product gets into eyes,rinse thoroughly with water

Stop use and ask a doctor If
rash appears
condition worsens or does not improve in 2-4 weeks

If pregnant or breast-feeding, ask a doctor befor use. Keep out of reach of children, If swallowed, get medical help or contact a Polson Control Center right away.

Water, Cocamidopropyl Betaine, Decyl Glucoside, Sodium Chloride, Panthenol, Sodium Lauryl Glycol Carboxylate, PEG-7 Glyceryl Cocoate, Caffeine, Menthol, Cucurbita Pepo (Pumpkin) Seed Oil, Benzyl Alcohol, Stearamidopropyl Dimethylamine, Mentha Piperita (Peppermint) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Guar Hydroxypropyltrimonium Chloride, Glycerin, Citric Acid, Phenoxyethanol, Serenoa Serrulata Fruit Extract, Benzoic Acid, Potassium Sorbate, Sorbic Acid, CI 15985, CI 19140.

How to use
-Use Ketoconazole Shampoo twice a week
-Rinse your hair, then pump out a coin sized amount of Ketoconazole dandruff shampoo
-Massage the anti dandruff shampoo into your wet scalp
-Leave Ketoconazole anti-dandruff shampoo for 2-3 minutes, then rinse thoroughly with water

store at 20℃ to 25℃（68 F-77F）

Gets to the root cause of dandruff by killing the fungus that causes it
So powerful it can even control severe dandruff
Helps control hair loss from dandruff
Only anti-dandruff shampoo with ketoconazole 1%, a powerful dandruff fighting ingredient
Safe to use on all hair types including color treated or chemically processed hair
Starts working from the first use

1 month
Nourishes dry scalp & reduce flakes

2 months
Anti-inflammatory properties relieve itching

3 months
Regulates oil production to fully prevent dandruff

Keep out of reach of children, If swallowed, get medical help or contact a Polson Control Center right away.

ELEVATE ANTI DANDRUFF 
elevate anti dandruff shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83830-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	20 mL  in 100 mL
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)	3 mL  in 100 mL
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)	1 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A)	0.5 mL  in 100 mL
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)	0.5 mL  in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	0.415 mL  in 100 mL
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)	0.3 mL  in 100 mL
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)	0.3 mL  in 100 mL
SORBIC ACID (UNII: X045WJ989B)	0.0005 mL  in 100 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.002 mL  in 100 mL
SAW PALMETTO (UNII: J7WWH9M8QS)	0.05 mL  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	1 mL  in 100 mL
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)	1 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.1 mL  in 100 mL
CAFFEINE (UNII: 3G6A5W338E)	0.5 mL  in 100 mL
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)	0.4 mL  in 100 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	0.3 mL  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	1.5 mL  in 100 mL
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)	0.0001 mL  in 100 mL
BENZOIC ACID (UNII: 8SKN0B0MIM)	0.01 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0001 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.125 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.075 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	67.9223 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83830-107-01	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/25/2024	03/07/2024

Labeler - Foshan Yilai Cosmetics Co., Ltd. (602056456)

Registrant - Foshan Yilai Cosmetics Co., Ltd. (602056456)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Yilai Cosmetics Co., Ltd.		602056456	manufacture(83830-107)

Revised: 3/2024

Document Id: 130e9565-1cce-9b05-e063-6294a90a444f

34390-5

Set id: 0e30eead-070c-fc26-e063-6294a90a3422

Version: 4

Effective Time: 20240307