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NDC 49035-0132-05 Equate Beauty Acne Foaming Cleanser 0.1 mg/g Details

Equate Beauty Acne Foaming Cleanser 0.1 mg/g

Equate Beauty Acne Foaming 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.

Product Information

NDC	49035-0132
Product ID	49035-132_35b9b047-8169-4537-aad7-07f1df0b6333
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 Beauty Acne Foaming Cleanser
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzoyl Peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.1
Active Ingredient Units	mg/g
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 49035-0132-05 (49035013205)

Pricing Information	N/A
NDC Package Code	49035-132-05
Billing NDC	49035013205
Package	156 g in 1 TUBE (49035-132-05)
Marketing Start Date	2017-07-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f2a2dacb-9fac-41ae-984e-6278b8dc698e 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), Glyceryl Stearate SE, Cetearyl Alcohol, Cetyl Alcohol, Propylene Glycol, Cocamidopropyl Betaine, Glycerin, Lactic Acid, Benzyl Alcohol, Mineral Oil, Sodium Laureth Sulfate, PEG-100 Stearate, Glyceryl Stearate, Ceteareth-20, Polysorbate 60, Carbomer, Titanium Dioxide (CI 77891).

Questions or comments?

1-888-287-1915

Label Copy

INGREDIENTS AND APPEARANCE

EQUATE BEAUTY ACNE FOAMING CLEANSER

benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-132
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	0.1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CARBOMER 934 (UNII: Z135WT9208)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-132-05	156 g in 1 TUBE; Type 0: Not a Combination Product	07/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	07/13/2017

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(49035-132)

Revised: 7/2017

Document Id: 35b9b047-8169-4537-aad7-07f1df0b6333

Set id: f2a2dacb-9fac-41ae-984e-6278b8dc698e

Version: 1

Effective Time: 20170714