FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

Manufacturer
HARMON STORES, INC. | FRUIT OF THE EARTH, INC.
Effective date
2020-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:39:02

Label at a glance#

ProductFACE VALUES ACNE MEDICATION
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Indications and uses

for the treatment of acne

Dosage and administration

Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Becasue excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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, apply ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Uses

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes, lips, and mouth
  • avoid unnecessary sun exposure and use a sunscreen
  • 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. Irritation may be reduced by using the product less frequently or in a lower concentration.
  • 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.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if • irritation becomes severe

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Becasue excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

1 OZ (28.3g)

NDC 63940-063-16

LabelLabel

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

BLISTER PACK

NDC 63940-063-17

Blister PackBlister Pack

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-06363940-063-16, 63940-063-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2502bdb1-e8c6-9052-e063-6394a90aa14ef66209a9-81dc-4271-8df2-1f4d5e047cb72024-10-21WarningsExact identifier
spl set id: f66209a9-81dc-4271-8df2-1f4d5e047cb7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.