L-Topical BENZOYL PEROXIDE 10% LOTION

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:45:40

Label at a glance#

ProductL-Topical BENZOYL PEROXIDE 10%
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

Important to use on a clean face. Cover the affected area with a thin layer 1 to 3 times per day. Because of excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day 1 morning and one evening if needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. If ir...

Storage and handling

Keep tightly closed. Protect from excessive heat (40° / 140° F) and protect from freezing

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only

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 1 topical acne medication at a time. • Avoid unnecessary sun exposure and use a sunscreen. • Avoid contact with the eyes, lips and mouth. • Avoid contact with hair or 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.

Do not use if you have very sensitive skin or sensitive to benzoyl peroxide.

STOP USE
Stop use and ask a doctor if irritation or sensitivity develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Keep tightly closed.
Protect from excessive heat (40° / 140° F) and protect from freezing

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Important to use on a clean face. Cover the affected area with a thin layer 1 to 3 times per day. Because of excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day 1 morning and one evening if needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. If irritation or sensitivity develops stop using both products and ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sulfur, PEG-8 SMDI Copolymer, Lactobacillus Ferment, Glycolic Acid, Lactic Acid, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Potassium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Hydrolyzed Algin, Zinc Sulfate, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Tangerina (Tangerine) Peel Oil

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST.

SPL UNCLASSIFIED SECTION

√ Acne Treatment Lotion

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L-TopicalL-Topical

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-034-042023-02-08C16284748780-1f386c649-a003-0266-e053-dadaa90a7c1aL-Topical BENZOYL PEROXIDE 10% LOTION
73921-034-042023-01-30C16284748780-1f386c649-a003-0266-e053-dadaa90a7c1aL-Topical BENZOYL PEROXIDE 10% LOTION

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-03473921-034-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
f42ad3c6-61dd-93da-e053-2a95a90a9fdc4145b228-14b7-498f-bc69-010f1b0e55432023-02-08WarningsExact identifier
spl set id: 4145b228-14b7-498f-bc69-010f1b0e5543

Reported adverse events (FAERS/openFDA)#

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