HUMANE ACNE WASH- benzoyl peroxide liquid

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

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Active ingredient:
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)
Available from:
Apprendista, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
for the treatment of acne.
Authorization status:
OTC monograph final
Authorization number:
73010-900-00

HUMANE ACNE WASH- benzoyl peroxide liquid

Apprendista, 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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Humane Acne Wash

Drug Facts

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne Treatment

Use

for the treatment of acne.

Warnings

For external use only.

Do not use

If you are sensitive to Benzoyl Peroxide or have very sensitive skin.

Using other topical acne drugs at the same time or right after use of this product may increase

dryness, redness or irritation of the skin.

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

increase to two to three times daily if needed. If bothersome dryness or peeling occurs, reduce

application to once a day or every other day.

When using this product

Avoid contact with and near eyes. If contact occurs, flush thoroughly with water. Keep away from

lips and mouth.

Avoid unnecessary sun exposure and use a sunscreen.

Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be

bleached by this product.

Stop use and ask a doctor

if excessive irritation occurs.

Keep out of reach of children.

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

Directions

New User: Test 1-2 small affected areas for sensitivity for 3 days. If no discomfort occurs, apply acne

wash and gently massage into damp skin. Wait 3-5 minutes for wash to absorb. Rinse thoroughly.

Inactive ingredients

Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate,

Sodium Hydroxide.

Package Labeling:

HUMANE ACNE WASH

benzoyl peroxide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 10 -9 0 0

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

10 0 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

GLUCO NO LACTO NE (UNII: WQ29 KQ9 POT)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

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

Apprendista, LLC

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 10 -9 0 0 -0 0

237 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 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 4/0 1/20 19

Labeler -

Apprendista, LLC (116995922)

Revised: 6/2019

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