NDC | 52000-025-03, 52000-025-06, 52000-025-07, 52000-025-31, 52000-025-32, 52000-025-40, 52000-025-41, 52000-025-42, 52000-025-43, 52000-025-44, 52000-025-45 |
Set ID | 091bea0c-7582-45d7-b04e-7d49d7fc4648 |
Category | HUMAN OTC DRUG LABEL |
Packager | Universal Distribution Center LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- Drug Facts
- 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 one week
Ask a doctor before use if you have • deep 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
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DOSAGE & ADMINISTRATION
Directions For use a first aid antiseptic:
• clean affected area
• apply small amount of product on affected area 1-3 times a day
• may be covered with a sterile bandage
• if bandage, let dry first
For use as an oral debriding agent (oral rinse):
• adults and children 2 years of age and over:
• mix with an equal amount of water
• swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.
• use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
• children under 12 years should be supervised in the use of this product
• children under 2 years of age:
consult a doctor or dentist
- Other information
- Inactive ingredient
-
SPL UNCLASSIFIED SECTION
Topical Solution USP 3%
First Aid Antiseptic/Oral Debriding Agent
For Treatment of Minor Cuts & Abrasions
For Use As a Gargle or Rinse
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Distributed by:
Universal Distribution Center
96 Distribution Boulevard
Edison, NJ 08817
Made in India
- Packaging
-
INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-025 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:52000-025-40 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 2 NDC:52000-025-41 119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 3 NDC:52000-025-42 178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 4 NDC:52000-025-43 200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 5 NDC:52000-025-03 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 6 NDC:52000-025-44 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 7 NDC:52000-025-45 266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 8 NDC:52000-025-31 295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 9 NDC:52000-025-32 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 10 NDC:52000-025-06 414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 11 NDC:52000-025-07 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/25/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/25/2015 Labeler - Universal Distribution Center LLC (019180459) Establishment Name Address ID/FEI Business Operations BIOTEK INDIA 675484458 manufacture(52000-025)