Label: APLICARE HYDROGEN PEROXIDE- hydrogen peroxide liquid
- NDC Code(s): 52380-0013-1
- Packager: Aplicare Products, 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.
Updated January 27, 2020
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- Active Ingredient
For external use only.
Stop use and ask a doctor if
- the condition persists or gets worse
- irritation, pain, or redness persists or worsens
- swelling, rash, or fever develops
- Other information
- Inactive ingredients
- Package Label
INGREDIENTS AND APPEARANCE
APLICARE HYDROGEN PEROXIDE
hydrogen peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-0013 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:52380-0013-1 30 mL in 1 PACKET; Type 0: Not a Combination Product 12/01/1983 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/01/1983 Labeler - Aplicare Products, LLC (081054904) Establishment Name Address ID/FEI Business Operations Aplicare Products, LLC 081054904 manufacture(52380-0013)