Label: 0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79635-019-01, 79635-019-02, 79635-019-03, 79635-019-04, view more79635-019-05 - Packager: BJ Goods 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.
Drug Label Information
Updated July 7, 2020
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- INDICATIONS & USAGE
- PURPOSE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
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WARNINGS
Warnings: For external use only. Flammable. Keep away from heat or flame.
Do not use: In children less than 2 months of age. On open skin wounds.
When using this product: Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if: irritation or rash occurs. These may by signs o a serious condition.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79635-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.14 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79635-019-03 240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/04/2020 2 NDC:79635-019-04 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/04/2020 3 NDC:79635-019-01 60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/04/2020 4 NDC:79635-019-05 3800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/04/2020 5 NDC:79635-019-02 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/04/2020 Labeler - BJ Goods LLC (117585173)