Label: ABUTOL SANITIZING LEMON AND MINT- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 77418-802-10 - Packager: ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI
- 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 5, 2020
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- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only. Protect from the sunlight.
Do not use
• on children less than 2 months of age
• on open skin woundsWhen using this product • Avoid use on/or around eyes, ears, mouth, broken/ irritated skin or large areas of body. In case of a contact with eyes, rinse thoroughly with water several minutes. do not inhale or ingest
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ABUTOL SANITIZING LEMON AND MINT
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77418-802 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 WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77418-802-10 1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/06/2020 Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248) Establishment Name Address ID/FEI Business Operations ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI 566218248 manufacture(77418-802)