L-Topical BENZOYL PEROXIDE 5% GEL

L-Topical BENZOYL PEROXIDE 5% Gel by

Drug Labeling and Warnings

L-Topical BENZOYL PEROXIDE 5% Gel 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% GEL- benzoyl peroxide gel 
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% GEL

DRUG FACTS

Active ingredient

Benzoyl peroxide 5%

Purpose

Acne treatment

Use

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  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.  Avoid unnecessary sun exposure and use a sunscreen  Avoid contact with the 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 THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

 Clean the skin thoroughly before applying this product  Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily  Because 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.

Other information

Store at 15°-30°C (59°-86°F).

Inactive ingredients

Allantoin, Aloe barbadensis leaf extract, Benzyl alcohol, Carbomer, Disodium EDTA, Disodium laureth sulfosuccinate, Glycerin, Panthenol, PEG-8, PPG-14 palmeth-60 hexyl dicarbamate, Sodium hyaluronate, Triethanolamine, Water

Questions?

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

√ Acne Treatment

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

LTopical31

L-TOPICAL BENZOYL PEROXIDE 5% GEL 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PPG-14 PALMETH-60 HEXYL DICARBAMATE (UNII: 376C96Y6AL)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-031-04118 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/202102/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-031)

Revised: 2/2023
 

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