SPOT ACNE TREATMENT- benzoyl peroxide 2.5% lotion

Spot Acne Treatment by

Drug Labeling and Warnings

Spot Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                             Purpose
Benzoyl peroxide 2.5% ................  ................. Acne Treatment

PURPOSE

INDICATIONS & USAGE

Uses Helps prevent new acne blemishes.

WARNINGS

Warnings
For external use only.
Do not use if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
Stop use and ask a doctor if irritation becomes severe.
When using this product:
■ avoid unnecessary sun exposure and use a sunscreen
■ using other topical acne drugs at the same time or right after use may increase dryness or irritation of skin.
If this occurs, only one drug should be used
■ 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
■ keep away from eyes, lips and mouth
■ avoid contact with hair and dyed fabrics, which may be bleached by this product

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center
right away.

DOSAGE & ADMINISTRATION

Directions
Cleanse skin thoroughly before applying. Cover entire affected area with a thin layer 1 to 3 times daily. Start
with one application daily, because excessive drying may occur. Then gradually increase to 2 or 3 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 use a sunscreen. Allow acne medication to dry before application of
sunscreen. If irritation or sensitivity develops, stop use of both products and ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients
Bentonite, Caprylic/Capric Triglyceride, Cetyl Dimethicone, Citric Acid, Disodium EDTA, Emulsifying Wax NF,
Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20,
Sodium Citrate, Water, Xanthan Gum.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPOT ACNE TREATMENT 
benzoyl peroxide 2.5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7784
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	Benzoyl Peroxide	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Bentonite (UNII: A3N5ZCN45C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Laurate (UNII: Y98611C087)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Citrate (UNII: 1Q73Q2JULR)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-7784-01	1 in 1 CARTON	10/23/2017
1		21 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/23/2017

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(0363-7784) , label(0363-7784)