ACNE DEFENSE DAILY TREATMENT SERUM MERLE NORMAN- benzoyl peroxide gel

Acne defense Daily Treatment Serum by

Drug Labeling and Warnings

Acne defense Daily Treatment Serum by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active (medicinal)                Purpose

Benzoyl Peroxide 2.5%   Acne Treatment   

PURPOSE

Uses 

For the treatment of acne

Dries and helps clear up acne pimples and allows skin to heal

helps prevent new acne pimples from forming

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if

• irritation becomes severe

WARNINGS

Warnings

For external use only

Do not use if

• have very senstive skin
• are sensitive to benzoyl peroxide

When using 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.

Avoid unnecessary sun exposure and use a sunscreen

avoid contact with eyes, lips  and mouth

avoid contact with hair and dyed fabrics which may be bleached by this product

Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irriration may be reduced by using the product less frequently or in a lower concentration

DOSAGE & ADMINISTRATION

Directions

• Clean the skin thoroughly before applying this product

• Cover the entire affected area with a thin layer 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 directed by a doctor. If bothersome dryness or peeing occurs, reduce application to once a day or every other day

• If going outside apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

INACTIVE INGREDIENT

Inactive (Non-medicinal) Ingredients

Water, Glycerin, Isopropyl Myristate, Pentylene Glycol, Polyacrylamide, C13-14 Isoparrafin, Laureth-7, Disodium EDTA

PRINCIPAL DISPLAY PANEL

Acne Defense Daily Treatment Serum

Gel

33g

Net Wt. 1.15 Oz

INGREDIENTS AND APPEARANCE

ACNE DEFENSE DAILY TREATMENT SERUM  MERLE NORMAN
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-202
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
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-202-02	1 in 1 CARTON	07/14/2017
1	NDC: 57627-202-01	33 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	07/14/2017

Labeler - Merle Norman Cosmetics (008479388)

Registrant - Merle Norman Cosmetics (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics		008479388	manufacture(57627-202)