Label: ALL CLEAN NATURAL ANTIBACTERIAL FOAMING HAND WASH- 0.13% benzalkonium chloride solution soap
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Contains inactivated NDC Code(s)
NDC Code(s): 78806-200-01, 78806-200-40 - Packager: All Clean Natural Ltd.
- 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 April 27, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients/ ingrédients actifs
- PURPOSE
- Use / Usage
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WARNING/ MISES EN GARDE
WHEN USING
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water/ Lorsque vous utilisez ce produit éviter tout contact avec les yeux. Le cas échéant, bien rincer avec de l'eau.
STOP USE
Stop use and ask a doctor if irritation develops / Cessez d'utiliser et consultez un médecin si une irritation se développe
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Directions / Mode d'emploi
Adults and children over 2 years: • For occasional
and personal domestic use • Supervise children when they use this product •
Lather in hands with water for at least 30 seconds. Rinse Adultes ét enfants
de plus de 2 ans: • Superviser les enfants du well. rant l'utilisation de ce produit
• Pour une utilisation occasionnelle pour usage domestique perssonnel • Faire
mousser dans les mains avec de l'eau pendant au moins 30 secondes.
Bien rincer - Inactive ingredients/ ingrédients inactifs
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALL CLEAN NATURAL ANTIBACTERIAL FOAMING HAND WASH
0.13% benzalkonium chloride solution soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78806-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.013 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL) 0.1 mL in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.03 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.7017 mL in 1 mL .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.01 mL in 1 mL DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.05 mL in 1 mL ALOE (UNII: V5VD430YW9) 0.01 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78806-200-01 300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/31/2021 2 NDC:78806-200-40 4000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/31/2021 Labeler - All Clean Natural Ltd. (203593355) Establishment Name Address ID/FEI Business Operations All Clean Natural Ltd. 203593355 manufacture(78806-200)
