LUCKY SUPER SOFT HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

LUCKY SUPER SOFT Hydrogen Peroxide by

Drug Labeling and Warnings

LUCKY SUPER SOFT Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, mucus, or other secretions associated with occasional sore mouth

Warnings

For external use only (as a first aid antiseptic).

Do not use

in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor

Stop use and consult a doctor if

the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

As oral debriding agent:

Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or swelling, rash, or fever develops, see your dentist or doctor promptly

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

for use as a first aid antiseptic: Clean the affected area. Apply a small amount of this product on affected area 1to 3 times a daily.

May be covered with a sterile bandage. If bandaged, let dry first

For use as an oral debriding agent:

Adults and children 2 years of age and older: Mix with an equal amount of warm water. Swish around in the mouth over 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 ingredients

purified water

Package Label

INGREDIENTS AND APPEARANCE

LUCKY SUPER SOFT HYDROGEN PEROXIDE  3 PERCENT
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-300
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 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-300-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/02/2021

Labeler - Delta Brands Inc (102672008)