Label: INO MED 2 HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78306-501-11, 78306-501-12, 78306-501-14, 78306-501-15 - Packager: GROUPE DISSAN, LE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated June 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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INACTIVE INGREDIENT
SQUALANE GW89575KF9 IACT
PANTHENOL WV9CM0O67Z IACT
AMINOMETHYLPROPANOL LU49E6626Q IACT
INULIN JOS53KRJ01 IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 59TL3WG5CO IACT
LIMONENE, (+)- GFD7C86Q1W IACT
ALPHA-TOCOPHEROL ACETATE 9E8X80D2L0 IACT
GLYCERIN PDC6A3C0OX IACT
WATER 059QF0KO0R IACT
HYALURONATE SODIUM YSE9PPT4TH IACT
FRUCTOSE, DL- 02T79V874P IACT - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INO MED 2 HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78306-501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength HYALURONATE SODIUM (UNII: YSE9PPT4TH) SQUALANE (UNII: GW89575KF9) PANTHENOL (UNII: WV9CM0O67Z) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) INULIN (UNII: JOS53KRJ01) FRUCTOSE, DL- (UNII: 02T79V874P) LIMONENE, (+)- (UNII: GFD7C86Q1W) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78306-501-12 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/13/2020 2 NDC:78306-501-14 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/13/2020 3 NDC:78306-501-11 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/13/2020 4 NDC:78306-501-15 3800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/13/2020 Labeler - GROUPE DISSAN, LE (248967291) Registrant - Normand Robichaud Services conseils Inc. (242225051) Establishment Name Address ID/FEI Business Operations GROUPE DISSAN, LE 248967291 manufacture(78306-501)
