Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5cc489f7-acbb-473f-bf79-95007219f3d1
Route
TOPICAL
Published
Effective Date 2017-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Glycolic Acid Medium-chain Triglycerides Cetearyl Olivate Sorbitan Olivate Cetostearyl Alcohol Dihexadecyl Phosphate Ceteth-10 Phosphate Azelaic Acid Glycerin Hexyl Laurate Lactic Acid Sorbitol Ammonia Butylene Glycol Cetyl Alcohol Ppg-12/smdi Copolymer Hyaluronate Sodium Yeast Propylene Glycol Symphytum Officinale Whole Plantago Ovata Seed Amino Acids Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Stearic Acid .alpha.-tocopherol Acetate Dimethicone Imperata Cylindrica Root Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Shea Butter Mangifera Indica Seed Butter Xanthan Gum Glycine Lavender Oil Ceramide 1 Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-04

Description

Salicylic Acid 2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses: Treats Acne, dries up Acne, helps prevent new acne

Dosage and Administration

Directions: Cleanse the skin thoroughly, then apply a hydration serum before applying the acne clarifying cream. Cover the affected and surrounding area with a thin layer. Avoid eye area. For evening or night use only

Description

Salicylic Acid 2%

Section 50565-1

if swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

stop use and ask a doctor if too much irritation or sensitivity developes or increases

Section 50567-7

when using this product:

avoid unnecessary sun exposure and use a sunscreen

do not use in or near the eyes

using other acne topical drugs at the same time or right after use of this product may increase dryness or irritation of the skin

Section 50570-1

do not use:

on a broken skin

if pregnant or lactating

Section 51727-6

Water (Aqua), Glycolic Acid, Caprylic/Capric triglyceride, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol and Dicetyl Phospahte, Ceteth 10 Phosphate, Azelaic Acid, Glycerin, Hexyl Laurate, Lactic Acid, Sorbitol, Ammonium Hydroxide, Butylene Glycol, Cetyl Alcohol, PPG-12/SMDI Copolymer, Sodium Hyaluronate, Yeast (Faex) Extract, Propylene Glycol, Symphytum Officinale Extract, Plantago Ovata Seed Extract, Amino Acids, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Stearic Acid, Tocopheryl Acetate, Dimethicone, Imperata Cylindrica Root Extract, Hydrolyzed Wheat Protein, Hydrolyzed Wheat Starch, Butyrospermum Parkii (Shea Butter), Mangifera Indica (Mango) Seed Butter, Xanthan Gum, Magnisium Aluminium Sulphate, Glycine, Lavandula Angustifolia (Lavender)Oil, Ceramides, Disodium EDTA   

Section 51945-4

Physicians Aesthetic Research, Inc., Distr.

San Clemente, CA 92672

Made in U.S.A.

www.lucrece.com

Section 55105-1

Acne Treatment Cream

Section 55106-9

Salicylic Acid 2%

Section 60561-8

Store at 20-25 C (68-77 F)


Structured Label Content

Indications and Usage (34067-9)

Uses: Treats Acne, dries up Acne, helps prevent new acne

Dosage and Administration (34068-7)

Directions: Cleanse the skin thoroughly, then apply a hydration serum before applying the acne clarifying cream. Cover the affected and surrounding area with a thin layer. Avoid eye area. For evening or night use only

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

if swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

stop use and ask a doctor if too much irritation or sensitivity developes or increases

Section 50567-7 (50567-7)

when using this product:

avoid unnecessary sun exposure and use a sunscreen

do not use in or near the eyes

using other acne topical drugs at the same time or right after use of this product may increase dryness or irritation of the skin

Section 50570-1 (50570-1)

do not use:

on a broken skin

if pregnant or lactating

Section 51727-6 (51727-6)

Water (Aqua), Glycolic Acid, Caprylic/Capric triglyceride, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol and Dicetyl Phospahte, Ceteth 10 Phosphate, Azelaic Acid, Glycerin, Hexyl Laurate, Lactic Acid, Sorbitol, Ammonium Hydroxide, Butylene Glycol, Cetyl Alcohol, PPG-12/SMDI Copolymer, Sodium Hyaluronate, Yeast (Faex) Extract, Propylene Glycol, Symphytum Officinale Extract, Plantago Ovata Seed Extract, Amino Acids, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Stearic Acid, Tocopheryl Acetate, Dimethicone, Imperata Cylindrica Root Extract, Hydrolyzed Wheat Protein, Hydrolyzed Wheat Starch, Butyrospermum Parkii (Shea Butter), Mangifera Indica (Mango) Seed Butter, Xanthan Gum, Magnisium Aluminium Sulphate, Glycine, Lavandula Angustifolia (Lavender)Oil, Ceramides, Disodium EDTA   

Section 51945-4 (51945-4)

Physicians Aesthetic Research, Inc., Distr.

San Clemente, CA 92672

Made in U.S.A.

www.lucrece.com

Section 55105-1 (55105-1)

Acne Treatment Cream

Section 55106-9 (55106-9)

Salicylic Acid 2%

Section 60561-8 (60561-8)

Store at 20-25 C (68-77 F)


Advanced Ingredient Data


Raw Label Data

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