CLEAR SMART BLEMISH SPOT TREATMENT- salicyclic acid gel

Clear Smart Blemish Spot Treatment by

Drug Labeling and Warnings

Clear Smart Blemish Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Salicylic Acid 1% Acne treatment tonic

PURPOSE

Uses

• Treats acne
• dries up acne pimples
• helps prevent new acne pimples

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

When using this product

• Using other topical acne medication at the same time or immediately following the use of this product may increase dryness of irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

WARNINGS

Warnings

For external use only

DOSAGE & ADMINISTRATION

Directions

• Clean the skin thoroughly before applying
• Cover the entire affected area with a thin layer 1 to 3 times daily
• Avoid contact with eyes.
• Becuase excessive drying may of the skin may occur, start with 1 application daily if needed or as directed by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT

Inactive ingredients

Allantoin, Bisabolol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Carbomer, Decylene Glycol, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Honey Extract, Hydrogenated Lecithin, Lecithin, Maltodextrin, Niacinamide, Phenethyl Alcohol, Phenoxyethanol, piraea Ulmaria Extract, Polyacrylate-13/Polyisobutene/ Polysorbate 20, Royal Jelly Powder, Royal Jelly, SD Alcohol 40-B, Sodium Hydroxide, Succinic Acid, Tetrapeptide-45, Water/Aqua, Zymomonas Ferment Extract.

PRINCIPAL DISPLAY PANEL

Jafra Royal

Clear Smart Blemish Spot Treatment

15 ml e .5 FL OZ (US)

INGREDIENTS AND APPEARANCE

CLEAR SMART BLEMISH SPOT TREATMENT 
salicyclic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-245
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
1-OCTENYLSUCCINIC ACID (UNII: S8BV67O5DP)
NIACINAMIDE (UNII: 25X51I8RD4)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HONEY (UNII: Y9H1V576FH)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROYAL JELLY (UNII: L497I37F0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-245-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/11/2020

Labeler - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-245)