Label: ANTISEPTIC HAND SANITIZER FOAM- ethyl alcohol aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 65584-105-12 - Packager: Higley Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
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 March 22, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable, keep away from fire/flame
For external use only
Do 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
Stop use and ask a doctor if
- irritation and redness develop
- condition persists for more than 72 hours
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ANTISEPTIC HAND SANITIZER FOAM
ethyl alcohol aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65584-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65584-105-12 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/19/2020 Labeler - Higley Industries, Inc. (005467626) Establishment Name Address ID/FEI Business Operations Higley Industries, Inc. 005467626 manufacture(65584-105)