Antiseptic Wound Care by Kadence Healthcare, Inc Antiseptic Wound Care

Antiseptic Wound Care by

Drug Labeling and Warnings

Antiseptic Wound Care by is a Otc medication manufactured, distributed, or labeled by Kadence Healthcare, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC WOUND CARE MEDICLEANSE HEALING- benzethonium chloride solution 
Kadence Healthcare, Inc

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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Antiseptic Wound Care

Drug Facts

Active ingredients

Benzethonium Chloride 0.13%

Purpose

First aid Antiseptic

Uses

First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.

Warnings

For external use only

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week, unless directed by a doctor
  • for single patient use only

Ask a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

When using this product

  • do not puncture or incinerate
  • contents under pressure

Stop use and consult a doctor if

  • condition persists or gets worse

Keep out of reach of children

Directions

  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times a day
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

  • Store between 59° and 86° F (15° and 30° C ).
  • See bottom of can for lot # and expiration date

Inactive ingredients

aloe barbadensis leaf extract (aloe vera), benzalkonium chloride, maltodextrin, purified water, sodium bicarbonate, sodium chloride

Questions?

1-888-547-5492

Package Labeling:

1

ANTISEPTIC WOUND CARE  MEDICLEANSE HEALING
benzethonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 46011-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46011-0003-2211 g in 1 BOTTLE; Type 0: Not a Combination Product06/28/202206/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/28/202206/28/2022
Labeler - Kadence Healthcare, Inc (784608650)

Revised: 8/2022
Document Id: e5c5b580-1d9e-3081-e053-2995a90a8031
Set id: e28d51f9-45c5-7ce6-e053-2a95a90a1ce7
Version: 2
Effective Time: 20220808