Label: HYDROGEN PEROXIDE liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 52000-025-03, 52000-025-06, 52000-025-07, 52000-025-31, view more52000-025-32, 52000-025-40, 52000-025-41, 52000-025-42, 52000-025-43, 52000-025-44, 52000-025-45 - Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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
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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
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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)
