CLEAR PROOF ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel

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

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Active ingredient:
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)
Available from:
Mary Kay Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Medication - for the management of acne - dries up acne pimples - helps prevent new acne pimples
Authorization status:
OTC monograph final
Authorization number:
51531-9071-0, 51531-9071-1

CLEAR PROOF ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel

Mary Kay 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.

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Clear Proof Acne Treatment Gel

Drug Facts

Active ingredient:

Benzoyl Peroxide 5%

Purpose

Acne Medication

Uses

for the management of acne

dries up acne pimples

helps prevent new acne pimples

Warnings

For external use only.

Do not use if you

have very sensitive skin

are sensitive to benzoyl peroxide

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the

same time. If irritation occurs, only use one topical acne medication at a time.

avoid unnecessary sun exposure and use a sunscreen

avoid contact with the eyes, lips and mouth

avoid contact with hair and dyed fabrics, which may be bleached by this product

skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling.

Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

irritation becomes severe

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 this product

cover the entire affected area with a thin layer one to three times daily

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

if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop

use of both products and ask a doctor.

Other information

store at 59° to 86° F

expiration date on tube crimp

Inactive ingredients

aesculus hippocastanum (horse chestnut) seed extract, butylene glycol, carbomer, cucumis sativus

(cucumber) fruit extract, diethylhexyl sodium sulfosuccinate, disodium EDTA, echinacea purpurea

extract, glycerin, poloxamer 182, propylene glycol, silica, sodium hydroxide, water

Principal Display Panel - 28 g carton

clearproof

acne treatment gel

acne medication

5% benzoyl peroxide

1 OZ. NET WT./28 g

Mary Kay

CLEAR PROOF ACNE TREATMENT ACNE MEDICATION

benzoyl peroxide gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51531-9 0 71

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO YL PERO XIDE (UNII: W9 WZN9 A0 GM) (BENZOYL PEROXIDE - UNII:W9 WZN9 A0 GM)

BENZOYL PEROXIDE 5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PO LO XAMER 18 2 (UNII: JX0 HIX6 OAG)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 4Q9 3RCW27E)

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

DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 )

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ECHINACEA PURPUREA (UNII: QI7G114Y9 8 )

CUCUMBER (UNII: YY7C30 VXJT)

HO RSE CHESTNUT (UNII: 3C18 L6 RJAZ)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51531-9 0 71-1

1 in 1 CARTON

0 8 /16 /20 16

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:51531-9 0 71-0

3 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /16 /20 16

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 6 /15/20 12

Labeler -

Mary Kay Inc. (049994452)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ko lmar Labo rato ries Inc.

0 0 153510 3

ma nufa c ture (51531-9 0 71)

Mary Kay Inc.

Revised: 8/2020

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