CLEAR SMART CLEAR PORE HYDRATOR- salicylic acid gel

Clear Smart Clear Pore Hydrator by

Drug Labeling and Warnings

Clear Smart Clear Pore Hydrator by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Salicylic Acid 0.5% 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

Alcohol, Allantoin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bisabolol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Decylene Glycol, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Honey Extract, Hydrogenated Lecithin, Lactobacillus Ferment, Laureth-7, Lecithin, Maltodextrin, Niacinamide, Panthenol, Phenethyl Alcohol, Phenoxyethanol, Polyacrylamide, Polyacrylate-13/Polyisobutene/Polysorbate-20, Royal Jelly Powder, Royal Jelly, Sodium Hydroxide, Sodium PCA,Spiraea Ulmaria Extract, Succinic Acid, Tetrapeptide-45, Water/Aqua, Zymomonas Ferment Extract

PRINCIPAL DISPLAY PANEL

Jafra Royal

Clear Smart

Clear Pore Hydrator

50ml e 1.7 FL OZ (US)

INGREDIENTS AND APPEARANCE

CLEAR SMART CLEAR PORE HYDRATOR 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-249
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DECYLENE GLYCOL (UNII: S57M60MI88)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PANTHENOL (UNII: WV9CM0O67Z)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HONEY (UNII: Y9H1V576FH)
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
ROYAL JELLY (UNII: L497I37F0C)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
SUCCINIC ACID (UNII: AB6MNQ6J6L)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
NIACINAMIDE (UNII: 25X51I8RD4)
ALLANTOIN (UNII: 344S277G0Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-249-01	50 mL in 1 BOTTLE; 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(68828-249)