Hydrogen Peroxide Solution [Dolgencorp, Llc] -

HYDROGEN PEROXIDE SOLUTION [DOLGENCORP, LLC]
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NDC	55910-871-38, 55910-871-43, 55910-871-45
Set ID	3c823b47-2ab7-4002-9b6f-abf0a3176b44
Category	HUMAN OTC DRUG LABEL
Packager	DOLGENCORP, LLC
Generic Name
Product Class
Product Number
Application Number	PART333A

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Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic/oral debriding agent
Uses

• first aid to help prevent the risk of infection in minor cuts, scrapes and burns
• aids in the removal of phlegm, mucous 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 than 1 week

As 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 9oral 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

•children under 12 years of age should be supervised in the use of this product
•children under 2 years of age: consult 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
adverse reactions

Distributed by

Old East Main

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072
principal display panel
Rexall
Hydrogen Peroxide Topical Solution USP

3% H202
- For treatment of minor cuts and abrasions
- First Aid Antiseptic
10 FL OZ (295 mL)
principal display panel
Hydrogen Peroxide Topical Solution USP
- First aid antiseptic
- Oral debriding agent
For treatment of minor cuts and abrasions

Do not use if printed seal under cap is broken or missing

100% satisfaction guaranteed (888)309-9030

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-871
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55910-871-43	.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/1989
2	NDC:55910-871-45	.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/1989
3	NDC:55910-871-38	.295 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/1989
4	NDC:55910-871-72	.295 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/15/1989

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/15/1989

Labeler - DOLGENCORP, LLC (068331990)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(55910-871)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(55910-871)

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Medic

HYDROGEN PEROXIDE SOLUTION [DOLGENCORP, LLC]

Purpose

Do not use

As a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

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