Label: HAND SANITIZER- isopropyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77110-400-05 - Packager: Biominerales Pharma
- 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 July 9, 2020
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- Active ingredient
- Purpose
- Inactive ingredients
- Use (s)
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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 or on open skin wounds. When using this product keep our 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
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- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77110-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302) Isopropyl alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Trolamine (UNII: 9O3K93S3TK) Hydrogen Peroxide (UNII: BBX060AN9V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77110-400-05 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 07/15/2020 Labeler - Biominerales Pharma (117489663) Establishment Name Address ID/FEI Business Operations Biominerales Pharma 117489663 MANUFACTURE(77110-400)