Label: UNSCENTED HAND SANITIZER- isopropyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 74877-110-01, 74877-110-02, 74877-110-03 - Packager: Plant Therapy, LLC
- 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 30, 2020
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active ingredient
- Purpose
- Use
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Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
• in children less than 2 months of age
• on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
UNSCENTED HAND SANITIZER
isopropyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74877-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74877-110-02 100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/20/2020 2 NDC:74877-110-01 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/20/2020 3 NDC:74877-110-03 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/20/2020 Labeler - Plant Therapy, LLC (080128261) Establishment Name Address ID/FEI Business Operations Plant Therapy, LLC 080128261 manufacture(74877-110)