Label: ABUTOL PARIS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77418-103-10 - 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 June 4, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable, keep away from fire / flame
For external use onlyDo not use• in children less than 2 months of age
• on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water. • Do not inhale or ingest.Stop and ask doctor if
• irritation and redness develop
• condition persists for more than 72 hours - Directions
- Other information
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ABUTOL PARIS ANTISEPTIC HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77418-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) FD&C Red No. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77418-103-10 1 in 1 CARTON 06/08/2020 1 80 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/08/2020 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(77418-103)