LUCKY SUPER SOFT HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid 
Delta Brands Inc

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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HydrgnPerxde3%Dlta

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

package label

LUCKY SUPER SOFT HYDROGEN PEROXIDE  3 PERCENT
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-300-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/02/2021
Labeler - Delta Brands Inc (102672008)

Revised: 12/2022
Document Id: eff53d24-636a-6fa7-e053-2995a90a23eb
Set id: cffcaa32-9793-365d-e053-2a95a90adc63
Version: 2
Effective Time: 20221216
 
Delta Brands Inc