Label: GERM CLEAN- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 77143-006-01 - Packager: NATURATLALI S DE RL DE CV
- 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 November 27, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
GERM CLEAN
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77143-006 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 GLYCERIN (UNII: PDC6A3C0OX) 0.7 mL in 100 mL IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 0.0625 mL in 100 mL WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) 1 mL in 100 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.003 mL in 100 mL CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) 0.125 mL in 100 mL GLYCERYL OLEATE (UNII: 4PC054V79P) 0.125 mL in 100 mL METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.0625 mL in 100 mL FRAGARIA VESCA FRUIT JUICE (UNII: 59KX3YNN28) 0.04 mL in 100 mL FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.08 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77143-006-01 350 mL in 1 POUCH; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2020 Labeler - NATURATLALI S DE RL DE CV (951577202) Establishment Name Address ID/FEI Business Operations NATURATLALI S DE RL DE CV 951577202 manufacture(77143-006) , pack(77143-006) , label(77143-006)
