Label: APLAUS HAND AND SKIN SANITIZER- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 71315-100-01, 71315-100-08, 71315-100-22, 71315-100-38, view more71315-100-50, 71315-100-55, 71315-100-60, 71315-100-99 - Packager: Katan Technologies USA, 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 January 13, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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- Active Ingredient
- Uses
- INSTRUCTIONS FOR USE
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Warnings
For external use only.
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
- STOP USE
- Ready to use. Do not dilute.
- Inactive Ingredients
- Questions
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PH Simply Hand & Skin Sanitiser
Drug Facts
Active ingredient Purpose
Benzalkonium Chloride 0.13%..................................Antimicrobial
Uses
•For hand and skin sanitizing
•Recommended for repeated useWarnings
For external use only
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
•Apply a small amount to hands or skin.
•Rub thoroughly over surfaces. Rub briskly until dry.Inactive ingredients Water, Polysilsesquioxane Steardimonium Chloride, fragrance
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INGREDIENTS AND APPEARANCE
APLAUS HAND AND SKIN SANITIZER
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71315-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4) 0.2 g in 100 mL WATER (UNII: 059QF0KO0R) 99.67 mL in 100 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71315-100-01 10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2017 2 NDC:71315-100-60 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2017 3 NDC:71315-100-08 80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2017 4 NDC:71315-100-22 220 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2017 5 NDC:71315-100-55 550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2017 6 NDC:71315-100-50 50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2017 7 NDC:71315-100-99 1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2017 8 NDC:71315-100-38 3780 mL in 1 JUG; Type 0: Not a Combination Product 05/01/2017 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/01/2017 Labeler - Katan Technologies USA, LLC (063773754)