Label: DOP HYDROGEN PEROXIDE 3%- hydrogen peroxide liquid
- NDC Code(s): 51048-040-08, 51048-040-16, 51048-040-32
- Packager: Omega & Delta Co. Inc.
- 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.
Updated December 2, 2015
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- Drug Facts
- Active Ingredient
- INDICATIONS & USAGE
Warnings For external use only
Do not use • in the eyes or apply over large areas of the body • do not use longer than 1 week
Ask a doctor before use if you have deep or punctured 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.
- KEEP OUT OF REACH OF CHILDREN
First aid antiseptic:
- clean the affected area
- apply small amount of product on the affected area 1 to 3 times a day
- 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 over:
- mix with an equal amount of 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 this product
- children under 2 years of age: consult a dentist or doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DOP HYDROGEN PEROXIDE 3%
hydrogen peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51048-040 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 g in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51048-040-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2000 2 NDC:51048-040-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2006 3 NDC:51048-040-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2000 Labeler - Omega & Delta Co. Inc. (090317793) Establishment Name Address ID/FEI Business Operations Omega & Delta Co. Inc. 090317793 manufacture(51048-040)