Label: CURAD HYDROGEN PEROXIDE- hydrogen peroxide liquid
- NDC Code(s): 53329-983-06, 53329-983-23
- Packager: Medline Industries, 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 18, 2017
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- Active ingredient
For external use only.
Stop use and ask a doctor if
- 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
First aid antiseptic:
- clean the affected area
- apply a small amount of product on the affected area 1 to 3 times daily
- may be covered with a sterile bandage
- if bandaged, let dry first
Oral debriding agent:
adults, children over 2 years of age:
- mix with an equal amount of water
- swish around in the mouth over the affected area for at least 1 minute, then spit out
- use up to 4 times daily after meals and at bedtime
- children under 12 years of age should be supervised in the use.
- children under 2 years of age: consult a dentist, doctor
- Other information
- Inactive ingredient
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
CURAD HYDROGEN PEROXIDE
hydrogen peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-983 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:53329-983-06 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2012 2 NDC:53329-983-23 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/01/2012 Labeler - Medline Industries, Inc. (025460908)