PSP HYDROGEN PEROXIDE- hydrogen peroxide liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RW Consumer Products Ltd

INN (International Name):

HYDROGEN PEROXIDE

Composition:

HYDROGEN PEROXIDE 30 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

• First aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Authorization status:

OTC monograph not final

Summary of Product characteristics

PSP HYDROGEN PEROXIDE- HYDROGEN PEROXIDE LIQUID
RW CONSUMER PRODUCTS LTD
_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._
----------
PSP HYDROGEN PEROXIDE 3 TOPICAL
_DRUG FACTS_
_ACTIVE INGREDIENT_
Hydrogen peroxide 3%
_PURPOSE_
First Aid Antiseptic
_USES_
• First aid to help prevent the risk of 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 one 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 DOCTOR
if the condition persists or gets worse
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
immediately. 1-800-
222-1222
_DIRECTIONS_
• clean the affected area
• spray a small amount of this product on the affected area 1 to 3
times a day
• may be covered with a sterile bandage
• if bandaged, let area dry first
_OTHER INFORMATION_
• keep tightly closed and at a controlled room temperature • do
not shake bottle • hold
away from face when opening • avoid contact with eyes
_INACTIVE INGREDIENT_
water
PACKAGE LABELING:
PSP HYDROGEN PEROXIDE
hydrogen peroxide liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69612-001
ROUTE OF ADMINISTRATION
TOPICAL
RW Consumer Products Ltd
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
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:69612-001-
10
296 mL in 1 BOTTLE; Type 0: Not a Combination
Product
03/01/2018
09/30/2022
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATI