HYDROGEN PEROXIDE solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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download SPC (SPC)
09-11-2023

active_ingredient:

HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)

MAH:

Laboratorios Jaloma, S.A. de C.V.

INN:

HYDROGEN PEROXIDE

composition:

HYDROGEN PEROXIDE 30 mg in 1 mL

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

First aid to help prevent infection in minor cuts, scrapes, and burns.

authorization_status:

OTC monograph not final

SPC

                                HYDROGEN PEROXIDE- HYDROGEN PEROXIDE SOLUTION
LABORATORIOS JALOMA, S.A. DE C.V.
----------
DRUG FACTS
_DRUG FACTS_
_ACTIVE INGREDIENT_
Hydrogen peroxide topical solution 3%
_PURPOSE_
First aid antiseptic
_USE_
First aid to help prevent infection in minor cuts, scrapes, and burns.
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
• in the eyes or apply over large areas of the body.
• longer than 1 week unless directed by a doctor.
ASK A DOCTOR BEFORE USE IF
you have deep or puncture wounds, animal bites or serious burns
STOP USE AND ASK A DOCTOR IF
• the condition persists or gets worse
KEEP OUT OF THE REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
• Clean the affected area
• Apply a small amount of this product on the area 1 to 3 times
daily
• May be covered with a sterile bandage
• Let the product dry
_OTHER INFORMATION_
Store the bottle tightly closed and away from heat.
_INACTIVE INGREDIENTS_
Acetanilide, ethyl alcohol, water.
_QUESTIONS OR COMMENTS?_
800 9811 542
PACKAGE LABELING:224ML
PACKAGE LABELING:448ML
PACKAGE LABELING:1L
HYDROGEN PEROXIDE
hydrogen peroxide solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:65055-501
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE -
UNII:BBX060AN9V)
HYDROGEN
PEROXIDE
30 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Laboratorios Jaloma, S.A. de C.V.
ACETANILIDE (UNII: SP86R356CC)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65055-
501-01
224 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
09/18/2013
2
NDC:65055-
501-02
448 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
09/18/2013
3
NDC:65055-
501-03
1 in 1 BOX
02/26/2022
3
1000 mL in 1 BOTTLE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMB
                                
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