FACE VALUES ACNE MEDICATION- benzoyl peroxide gel 
HARMON STORES, INC.

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.

----------

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Uses

for the treatment of acne

Warnings

For external use only

Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide 

When using this product

Stop use and ask a doctor if • irritation becomes severe

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

Directions

Inactive ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

1 OZ (28.3g)

NDC 63940-063-16

Label

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

BLISTER PACK

NDC 63940-063-17

Blister Pack

FACE VALUES ACNE MEDICATION 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
LAURETH-4 (UNII: 6HQ855798J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-063-171 in 1 CARTON11/15/2010
1NDC:63940-063-1628.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/15/2010
Labeler - HARMON STORES, INC. (804085293)
Registrant - FRUIT OF THE EARTH, INC. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
FRUIT OF THE EARTH, INC.008193513manufacture(63940-063)

Revised: 3/2020
Document Id: 0d3d3ebc-22fa-433d-9aea-19605279985f
Set id: f66209a9-81dc-4271-8df2-1f4d5e047cb7
Version: 1
Effective Time: 20200323
 
HARMON STORES, INC.