HYDROGEN PEROXIDE- hydrogen peroxide liquid 
EXPORTADORA IN AND OUT S DE RL DE CV

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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Active ingredient

Hydrogen peroxide 3%

Purpose

First aid antiseptic/oral debriding agent

USES

-First aid to help prevent the risk of infection in minor cuts, scraps and burns

WARNING

For external use only

DO NOT USE

-in the eyes or apply over large areas of the body
-longer than one week

Ask a doctor before use if you have

-deep puncture wounds, animal bites or serious burns

STOP USE AND ASK A DOCTOR IF

-swelling, rash or fever develops
-the condition persists or gets worse
-sore mouth symptoms do not improve in 7 days
-irritation, pain, or redness persists or worsen

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away

DIRECTIONS

For use as a first aid antiseptic:
-clean affected area
-if bandaged, let dry first
-apply small amount of product on affected area 1-3 times a day
-may be covered with a sterile bandage
For use as an oral debriding agent (oral rinse)
-adults and children 2 years of age and over
-mix with and equal amount of water
-swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow
-use up to 4 times daily after meals and bedtime or a directed by a dentist or doctor
children under 12 years should be supervised in the use of this product
children under 2 years of age: consult a doctor or dentist

OTHER INFORMATION

-keep tightly close and in a dark place at room temperature
-do not shake bottle: hold away from face when opening

INACTIVE INGREDIENT

Purified water

Principal Display

Label Margrey
Hydrogen peroxide
Topical solution USP
Do not use if seal under cap
is broken or missing
32FL OZ 946ml

Distributed by BROSANT Group LLC, 15900 La cantera Parkway Suite 20255, San Antonio TX 78256, USA
Telephone: (210) 568-0444

HYDROGEN PEROXIDE 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77210-0035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 70 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77210-0035-1946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/17/2022
Labeler - EXPORTADORA IN AND OUT S DE RL DE CV (951577298)
Registrant - MARGREY INDUSTRIAL SA DE CV (814572392)
Establishment
NameAddressID/FEIBusiness Operations
MARGREY INDUSTRIAL SA DE CV814572392manufacture(77210-0035)

Revised: 10/2022
Document Id: eb415ebb-ab42-a816-e053-2995a90abd4b
Set id: eb415ebb-ab41-a816-e053-2995a90abd4b
Version: 1
Effective Time: 20221017
 
EXPORTADORA IN AND OUT S DE RL DE CV