APLICARE HYDROGEN PEROXIDE- hydrogen peroxide liquid 
Aplicare Products, LLC

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.

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0013 Aplicare Hydrogen Peroxide

Active Ingredient

Hydrogen peroxide USP 3%

Purpose

First Aid Antiseptic

Use

Warnings

For external use only.

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week

Ask a doctor before use if you have

  • deep or puncture wounds, animal bites, or serious burns

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Package Label

Label Packet

APLICARE HYDROGEN PEROXIDE 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0013-130 mL in 1 PACKET; Type 0: Not a Combination Product12/01/1983
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/01/1983
Labeler - Aplicare Products, LLC (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC081054904manufacture(52380-0013)

Revised: 1/2020
Document Id: 9d2275c8-0c29-d2b3-e053-2995a90a368e
Set id: eca20774-4f35-448f-9e22-ad93d0e818c2
Version: 4
Effective Time: 20200127
 
Aplicare Products, LLC