Label: HAND SANITIZER-GEL- dial professional gel hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50663-003-01, 50663-003-02, 50663-003-03, 50663-003-04, view more50663-003-05 - Packager: Zotos International Inc
- 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, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient(s)
- Purpose
- Use
- Warnings
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WHEN USING
When using this product keep avoid contact with face, eyes, and broken skin. if eye contact occurs, flush thoroughly with water and seek medical advice.
Stop use and ask a doctor if irritation or redness develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Questions
- Legal entity
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER-GEL
dial professional gel hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50663-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 60.146532 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.4985 mL in 100 mL WATER (UNII: 059QF0KO0R) 38.191 mL in 100 mL Propylene Glycol (UNII: 6DC9Q167V3) 0.5 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.14725 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.297 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.147 mL in 100 mL TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.072264 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50663-003-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 2 NDC:50663-003-02 221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 3 NDC:50663-003-03 443 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 4 NDC:50663-003-04 473 mL in 1 CELLO PACK; Type 0: Not a Combination Product 05/01/2020 5 NDC:50663-003-05 800 mL in 1 CELLO PACK; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/01/2020 Labeler - Zotos International Inc (966706145)
