SA FOAMING CLEANSER- salicylic acid cleanser soap

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Essay Cosmetics Group LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Medication USE For acne control and treatment
Authorization status:
OTC monograph final
Authorization number:
72900-022-90

SA FOAMING CLEANSER- salicylic acid cleanser soap

Essay Cosmetics Group LLC

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.

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SA Foaming Cleanser-Essay

Active Ingredient

1% Salicylic Acid

Product Purpose

Acne Medication

Product Use

USE For acne control and treatment

Directions

Directions [bullet] cleanse 1-2 time daily. [bullet] wet the face. Apply this product to the hands, add

water and work into a lather. [bullet] massage the skin gently for about 15 seconds. [bullet] rinse off

thoroughly. [bullet] because excessive drying of the skin may occur, start with one application daily,

then gradually increase to twice daily if needed or as directed by a doctor [bullet] if bothersome

dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

Inactive ingredients Water, Cocoamindopropyl Betaine, Sodium Cocoyl Apple Amino Acid, Decyl

glucoside, Glycerin, Salicylic Acid, PEG-7 Glyceryl Cocoate, Propanediol, Sodium Hydroxide,

Xanthan Gum, Allantoin, Propylene Glycol, Sodium EDTA, Melaeuca Alternifolia (Tea Tree) Oil,

Diazolidinyl Urea, Iodopropynyl Butylcarbamate

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

cleanse 1-2 time a daily

wet the face. Apply this product to the hands, add water and work into a lather.

massage the skin gently for about 15 seconds

rinse off thoroughly

because excessive drying of the skin may occur, start with one application daily, then gradually

increase to two or three 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.

Warnings: ■ for external use only ■ when using this product, skin irritation and dryness is more likely

to occur if you use another topical acne mediation at the same time. If irritation occurs, only use one

topical acne medication at a time.

Principal Display Panel

SA_Foaming_Cleanser_RF.jpg

SA FOAMING CLEANSER

salicylic acid cleanser soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:729 0 0 -0 22

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

1.2 g in 1.2 g

Inactive Ingredients

Ingredient Name

Stre ng th

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

DECYL GLUCO SIDE (UNII: Z17H9 7EA6 Y)

GLYCERIN (UNII: PDC6 A3C0 OX)

PEG-7 GLYCERYL CO CO ATE (UNII: VNX7251543)

SO DIUM CO CO YL APPLE AMINO ACIDS (UNII: EB3U1PA6 1T)

AMINO ACIDS, SILK (UNII: V0 L0 0 EX1IA)

ALLANTO IN (UNII: 344S277G0 Z)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Essay Cosmetics Group LLC

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

TEA TREE O IL (UNII: VIF56 5UC2G)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:729 0 0 -0 22-

1.2 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/28 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

0 2/28 /20 19

Labeler -

Essay Cosmetics Group LLC (085448126)

Revised: 4/2019

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