L-Topical BENZOYL PEROXIDE 5% LOTION

L-Topical BENZOYL PEROXIDE 5% by

Drug Labeling and Warnings

L-Topical BENZOYL PEROXIDE 5% by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L-TOPICAL BENZOYL PEROXIDE 5%- benzoyl peroxide lotion 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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L-Topical BENZOYL PEROXIDE 5% LOTION

DRUG FACTS

Active ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Use

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

Warnings

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.

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

Directions

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

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

Other Information

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

Questions?

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

√ Acne Treatment Lotion

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

L-TOPICAL BENZOYL PEROXIDE 5% 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LANOLIN OIL (UNII: OVV5IIJ58F)
LAURETH-4 (UNII: 6HQ855798J)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-033-04	118 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2021	02/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-033)

Revised: 2/2023

Document Id: f42c0a9d-9777-70a9-e053-2a95a90aa702

34390-5

Set id: 79653cd2-99ec-4a1d-b5ff-150001d4f7e2

Version: 2

Effective Time: 20230208