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NDC 49035-0829-05 Equate Clear Complexion Facial Cleanser 100 mg/mL Details

Equate Clear Complexion Facial Cleanser 100 mg/mL

Equate Clear Complexion Facial Cleanser is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-mart Stores Inc. The primary component is BENZOYL PEROXIDE.

MedlinePlus Drug Summary

Benzoyl peroxide is used to treat mild to moderate acne.

Related Packages: 49035-0829-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical

Product Information

NDC	49035-0829
Product ID	49035-829_7d8a2e59-5602-488a-9775-8ff940cffc03
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Equate Clear Complexion Facial Cleanser
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzoyl Peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/mL
Substance Name	BENZOYL PEROXIDE
Labeler Name	Wal-mart Stores Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2022-12-31

Package

Package Images

NDC 49035-0829-05 (49035082905)

Pricing Information	N/A
NDC Package Code	49035-829-05
Billing NDC	49035082905
Package	148 mL in 1 TUBE (49035-829-05)
Marketing Start Date	2016-12-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a06ed13a-2ecf-43b9-8599-4cdc2b707b0b Details

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne medication

Uses

for the treatment and prevention of 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

avoid unnecessary sun exposure and use a sunscreen
if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
avoid contact with eyes, lips and mouth
avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by 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
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

skin irritation or redness becomes severe.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

cleanse the skin thoroughly before applying this product
cover the entire affected area with a thin layer and rinse thoroughly 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.

Other information

keep tightly closed
store at controlled room temperature 20°C - 25°C (68°F - 77°F)

Inactive ingredients

Water (Aqua), Petrolatum, Cetyl Alcohol, Steareth-2, Zinc Lactate, Glycerin, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance (Parfum), Benzyl Alcohol, Disodium EDTA, Laureth-4, BHT, Menthol.

Questions or comments?

1-888-287-1915

Label Copy

INGREDIENTS AND APPEARANCE

EQUATE CLEAR COMPLEXION FACIAL CLEANSER

benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-829
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-2 (UNII: V56DFE46J5)
ZINC LACTATE (UNII: 2GXR25858Y)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-4 (UNII: 6HQ855798J)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MENTHOL (UNII: L7T10EIP3A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-829-05	148 mL in 1 TUBE; Type 0: Not a Combination Product	12/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	12/14/2016

Labeler - Wal-mart Stores Inc (051957769)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(49035-829)

Revised: 12/2016

Document Id: 7d8a2e59-5602-488a-9775-8ff940cffc03

Set id: a06ed13a-2ecf-43b9-8599-4cdc2b707b0b

Version: 1

Effective Time: 20161215