HUMCO HYDROGEN PEROXIDE- hydrogen peroxide 3% liquid

Humco Hydrogen Peroxide by

Drug Labeling and Warnings

Humco Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Hydrogen Peroxide 3%

Purpose

Antiseptic

Uses

As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

SPL UNCLASSIFIED SECTION

As an oral rinse for temporary use in cleaning of minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury.

Warnings

For external use except when used as an oral rinse.

Do not use in the eyes.

Do not apply over large areas of the body.

Do not use longer than 1 week unless directed by a dentist or doctor.

Ask a doctor before use if you have:

deep or puncture wounds, animal bites, serious burns.

Stop use consult a dentist or doctor if:

condition persists or gets worse, sore mouth symptoms do not improve in 7 days, irritation, pain, redness or fever develop.

Keep out of reach of children.

In case of acciedntal ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

For antiseptic use: Clean the affected area, apply a small amount on the area 1 to 3 times daily.

For oral rinse use: Adults and children 2 years and older mix with an equal amount of water and swish around and over the affected area then spit out. Use up to 4 times daily or as directed by a dentist or a doctor.

Children under 2 years of age: consult a doctor.

Other information

Keep tightly closed and at controlled room temperature 15-30C (59-86F).

Do not shake.

Inactive ingredient

Purified water

Principal package display

Label 16 oz

New Label

INGREDIENTS AND APPEARANCE

HUMCO HYDROGEN PEROXIDE 
hydrogen peroxide 3% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-1113
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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-1113-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/30/2017
2	NDC: 0395-1113-18	3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/30/2017
3	NDC: 0395-1113-94	113 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/25/1998

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding group, Inc.		825672884	label(0395-1113) , manufacture(0395-1113) , pack(0395-1113) , analysis(0395-1113)