Mark. Back Up Plan Anti-Acne Back Treatment (Salicylic Acid) Spray [Avon Products, Inc.] -

MARK. BACK UP PLAN ANTI-ACNE BACK TREATMENT (SALICYLIC ACID) SPRAY [AVON PRODUCTS, INC.]
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NDC	10096-0192-1, 10096-0192-2
Set ID	5e58ed4b-0044-41d7-80e1-ffc207a16c4f
Category	HUMAN OTC DRUG LABEL
Packager	Avon Products, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333

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ACTIVE INGREDIENT

Active/Medicinal ingredient Purpose
Salicylic Acid 2.0%..................Acne Treatment
INDICATIONS & USAGE

Uses
• helps in the treatment of acne
• helps clear up acne blemishes
• helps prevent new acne blemishes
from forming
• penetrates pores to eliminate most
blackheads and acne pimples
WARNINGS

Warnings
For external use only

When using this product
• avoid contact with eyes. If product
contacts eyes, rinse thoroughly with water.
• if excessive skin irritation develops or
increases, discontinue use. If irritation
persists, consult a health care practitioner.
• using other topical acne products at the
same time or immediately following use of
this product may increase dryness or
irritation of the skin. If this occurs, only one
product should be used unless directed by
a health care practitioner

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

Flammable. Keep away from heat or flame.
DOSAGE & ADMINISTRATION

Directions
• cleanse skin thoroughly with non-medicated
cleanser before applying medication
• apply to blemish-prone areas one to
three times daily or as directed by a
health care practitioner
• because excessive drying of the skin
may occur, start with one application daily,
then gradually increase to two to three times
daily if needed or as directed by a
health care practitioner
• if bothersome dryness or peeling occurs,
reduce application to once a day or
every other day
INACTIVE INGREDIENT

Inactive/Non-medicinal ingredients:
Water/Eau, SD Alcohol 40-B, Hamamelis
Virginiana (Witch Hazel) Extract, Pyrus Malus
(Apple) Fruit Extract, Cinnamomum Cassia
Bark Extract, Trideceth-9, Potassium
Hydroxide, Citric Acid, Disodium EDTA,
Pyridoxine HCL.
QUESTIONS

Questions? Call 1-800-FOR-AVON or
1-800-265-AVON in Canada
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MARK. BACK UP PLAN ANTI-ACNE BACK TREATMENT
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10096-0192
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	4.72 mL in 118 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

#	Item Code	Package Description
Packaging
1	NDC:10096-0192-2	1 in 1 CARTON
1	NDC:10096-0192-1	118 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	12/29/2009

Labeler - Avon Products, Inc. (001468693)

Name	Address	ID/FEI	Business Operations
Establishment
Avon Products, Inc.		001807106	manufacture

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Medic