0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER- hand sanitizer gel 
BJ Goods 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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Keep out of reach of children

Keep out of reach of children

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Indications & Usage Section

Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Dosage form: Gel

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage

Benzalkonium Chloride 0.13% v/v

Active Ingredient

Warnings: For external use only. Flammable. Keep away from heat or flame.

Warnings

Do not use: In children less than 2 months of age. On open skin wounds.

Do not use

When using this product: Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

warnings_1

Stop use and ask a doctor if: irritation or rash occurs. These may by signs o a serious condition.

Stop use

Aloe, glycerin, sterile distilled water

Inactive Ingredients

Anti-Bacterial Hand Sanitizer (Disinfectant Gel) free - alcohol

3.8L label NDC: 79635-019-05

3.8L Label

60 ml label NDC:79635-019-01

100 ml label NDC: 79635-019-02

240 ml label NDC: 79635-019-03

500 ml label NDC: 79635-019-04

60/100/240/500 ml labels

0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79635-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.14 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) 0.1 g  in 100 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) 0.1 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.09 g  in 100 mL
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) 0.5 g  in 100 mL
WATER (UNII: 059QF0KO0R) 96.08 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79635-019-03240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
2NDC:79635-019-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
3NDC:79635-019-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
4NDC:79635-019-053800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
5NDC:79635-019-02100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/04/2020
Labeler - BJ Goods LLC (117585173)

Revised: 7/2020
Document Id: a9a6b624-d6da-8373-e053-2a95a90a85e3
Set id: a9a6b624-d6d9-8373-e053-2a95a90a85e3
Version: 1
Effective Time: 20200707
 
BJ Goods LLC