Clear Smart Clear Complexion Toner: Package Insert and Label Information

CLEAR SMART CLEAR COMPLEXION TONER- salicylic acid liquid
Jafra Cosmetics International Inc

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.

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne treatment

Uses

Treats acne
Dries up acne pimples
Helps prevent new acne pimples

Warnings

For external use only

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

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

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.
• Because excessive drying may of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times 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 ingredients

Allantoin, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Honey Extract, Hydrogenated Lecithin, Lecithin, Maltodextrin, Menthyl Lactate, Niacinamide, PEG-40 Hydrogenated Castor Oil, Phenethyl Alcohol, Phenoxyethanol, PPG-26-Buteth-26, Royal Jelly Powder, Royal Jelly, SD Alcohol 40-B, Sodium Hydroxide, Tetrapeptide-45, Water/Aqua, Zymomonas Ferment Extract

Product label

CLEAR SMART CLEAR COMPLEXION TONER salicylic acid liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-289 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength HONEY NIACINAMIDE HAMAMELIS VIRGINIANA TOP MALTODEXTRIN PPG-26-BUTETH-26 POLYOXYL 40 HYDROGENATED CASTOR OIL PHENYLETHYL ALCOHOL PHENOXYETHANOL HYDROGENATED SOYBEAN LECITHIN SODIUM HYDROXIDE WATER DIPROPYLENE GLYCOL LECITHIN, SOYBEAN MENTHYL LACTATE, (-)- ETHYLHEXYLGLYCERIN ROYAL JELLY ALLANTOIN BUTYLENE GLYCOL EDETATE DISODIUM SHEA BUTTER GLYCERIN ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68828-289-01 200 mL in 1 BOTTLE None 2 NDC:68828-289-02 11 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/07/2020

Labeler — Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture (68828-289)

Revised: 05/2022 Jafra Cosmetics International Inc