L-Topical BENZOYL PEROXIDE 10% LOTION

L-Topical BENZOYL PEROXIDE 10% by

Drug Labeling and Warnings

L-Topical BENZOYL PEROXIDE 10% 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 10%- 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 10% LOTION

DRUG FACTS

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

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.

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

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

DIRECTIONS

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

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?

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

L-TOPICAL BENZOYL PEROXIDE 10% 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
SULFUR (UNII: 70FD1KFU70)  
PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6)  
LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
ORANGE OIL (UNII: AKN3KSD11B)  
MANDARIN OIL (UNII: NJO720F72R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-034-04118 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(73921-034)

Revised: 2/2023
 

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