ACNE DEFENSE DAILY TREATMENT SERUM MERLE NORMAN- benzoyl peroxide gel 
Merle Norman Cosmetics

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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Acne Defense Daily Treatment Serum

Active (medicinal)                Purpose

Benzoyl Peroxide 2.5%   Acne Treatment   

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

Stop use and ask a doctor if

Warnings

For external use only

Do not use if

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

Directions

Inactive (Non-medicinal) Ingredients

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

Acne Defense Daily Treatment Serum

Gel

33g

Net Wt. 1.15 Oz

carton

tube

ACNE DEFENSE DAILY TREATMENT SERUM  MERLE NORMAN
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-202-021 in 1 CARTON07/14/2017
1NDC:57627-202-0133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/14/2017
Labeler - Merle Norman Cosmetics (008479388)
Registrant - Merle Norman Cosmetics (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman Cosmetics008479388manufacture(57627-202)

Revised: 1/2020
Document Id: 0794a375-64b8-448b-8f50-5633ad7f054b
Set id: 04abb861-798e-4bcb-8d03-de70f8e1cc67
Version: 3
Effective Time: 20200127
 
Merle Norman Cosmetics