NATURAL CONCEPTS ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride gel 
Apollo Health and Beauty Care 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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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Do not use

  • on children less than 2 months of age
  • on open skin wounds

Stop use and ask a doctor if

irritation develops.

Keep out of reach of children.

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

Directions

Inactive ingredients

Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

Questions?

1-866-695-3030

Label copy

image of the label

NATURAL CONCEPTS ALCOHOL-FREE HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-512
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-512-373785 mL in 1 PACKAGE; Type 0: Not a Combination Product07/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/16/2020
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(63148-512)

Revised: 7/2020
Document Id: efe575ac-5c02-4ff5-8477-fa809af856ce
Set id: b2beed06-ee8c-4f26-9afe-cc8b3b179a37
Version: 1
Effective Time: 20200717
 
Apollo Health and Beauty Care Inc.