Hydrogen Peroxide

Hydrogen Peroxide

Drug Labeling and Warnings

Drug Details

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HYDROGEN PEROXIDE- hydrogen peroxide solution 
Rite Aid

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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Hydrogen Peroxide

Active ingredient

Hydrogen peroxide(stabilized) 3%

Purpose

First aid antiseptic
Oral debriding agent

Use

first aid to help prevent the rise of infection in minor cuts, scrapes and burns aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

for external use only

Do not use

in the eyes or apply over large areas of the body
longer then 1 week

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
sore mouth symptoms do not improve in 7 days
irritation, pain or redness persists or worsens
swelling, rash, or fever develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

First aid antiseptic:
clean the affected area
apply a small amount of product on the affected area 1 to 3 times a day
may be covered with a sterile bandage
if bandaged, let dry first
Oral debriding agent (oral rinse): adults and children 2 years of age and over:
mix with an equal amount of water
swish around in the mouth over the affected area for at least 1 minute and then spit out
use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor

Other information

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive ingredient

purified water

DISTRIBUTED BY: RITE AID
30 HUNTER LANE, CAMP HILL PA 17011

RITE AID PHARMACY
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
hydrogen peroxide topical solution USP
hydrogen peroxide 3%
first aid antiseptic
oral debriding agent
16 fl oz (1 PT) 473 mL

871.001/871AA

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0871
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	.3 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0871-4	.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/1993
2	NDC: 11822-0871-5	.710 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/11/1993

Labeler - Rite Aid (014578892)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(11822-0871)

Revised: 12/2018

Document Id: be06427c-1310-4597-8d69-ea3dedb5fb47

34390-5

Set id: 431d4932-22d8-46db-8412-afb6728b52b9

Version: 4

Effective Time: 20181226

 

Rite Aid