NDC | 61734-010-01, 61734-010-02, 61734-010-03, 61734-010-04, 61734-010-05, 61734-010-06, 61734-010-07 |
Set ID | d4aa09bf-8207-47dd-bc42-01e660da9438 |
Category | HUMAN OTC DRUG LABEL |
Packager | Delon Laboratories (1990) Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Do not use
- in the eyes or apply over large areas of the body
- longer than 1 week unless directed by a doctor or dentist
-
Directions
first aid antiseptic:
- clean the affected area
- apply a small amount of this product on the area 1 to 3 times daily
- 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 older:
- mix with an equal amount of warm 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 the product
- children under 2 years of age: consult a dentist or doctor
- Other information
- Inactive ingredient
- Delon Hydrogen Peroxide 3%
-
INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61734-010 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) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61734-010-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2014 2 NDC:61734-010-02 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2014 12/07/2014 3 NDC:61734-010-03 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2014 12/04/2014 4 NDC:61734-010-04 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2014 12/04/2014 5 NDC:61734-010-05 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2014 12/04/2014 6 NDC:61734-010-06 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/08/2014 12/04/2014 7 NDC:61734-010-07 175 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/08/2014 10/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/08/2014 Labeler - Delon Laboratories (1990) Ltd (248364184) Establishment Name Address ID/FEI Business Operations Delon Laboratories (1990) Ltd 243387722 label(61734-010) , manufacture(61734-010) , pack(61734-010)