L-Topical BENZOYL PEROXIDE 5% LOTION

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:45:41

Label at a glance#

ProductL-Topical BENZOYL PEROXIDE 5%
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

• Wash hands with a non-medicated soap (contains no Benzoyl Peroxide). • Cleanse and dry face thoroughly 5 minutes before use. • Using fingertips apply evenly to affected areas. • Use both morning and night or as directed by a physician. • If dryness or peeling occurs, reduce application to once a day or every other day. • Fair- skinned individuals should begin with one application. • For more severe cases, and/or...

Storage and handling

• Store at room temperature (59-86°F / 15-30°C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you are
• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Do not use if you
• Have very sensitive skin. • Are sensitive to Benzoyl Peroxide.

When using this product
• 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. Irritation may be reduced by using the product less frequently or in a lower concentration.

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

• Wash hands with a non-medicated soap (contains no Benzoyl Peroxide). • Cleanse and dry face thoroughly 5 minutes before use. • Using fingertips apply evenly to affected areas. • Use both morning and night or as directed by a physician. • If dryness or peeling occurs, reduce application to once a day or every other day. • Fair- skinned individuals should begin with one application. • For more severe cases, and/or if substantial improvement is not apparent within 3 to 4 weeks, consult a health care practitioner.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

C13-14 Isoparaffin, Ethylhexylglycerin, Lanolin Oil, Laureth-4, Laureth-7, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Water/Eau, Xanthan Gum.

Other Information

STORAGE AND HANDLING SECTION

• Store at room temperature (59-86°F / 15-30°C)

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

LTopical33LTopical33

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-033-042023-02-08C16284748780-1f386c64a-2f40-0266-e053-dadaa90a7c1aL-Topical BENZOYL PEROXIDE 5% LOTION
73921-033-042023-01-30C16284748780-1f386c64a-2f40-0266-e053-dadaa90a7c1aL-Topical BENZOYL PEROXIDE 5% LOTION

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-03373921-033-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
f42c0a9d-9777-70a9-e053-2a95a90aa70279653cd2-99ec-4a1d-b5ff-150001d4f7e22023-02-08WarningsExact identifier
spl set id: 79653cd2-99ec-4a1d-b5ff-150001d4f7e2

Reported adverse events (FAERS/openFDA)#

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