Label: HAND SANITIZER- isopropyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78240-001-02 - Packager: Lokahi Brewing Company LLC
- 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 June 19, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients.
- Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerin (4% v/v).
- Hydroxyethylcellulose (1.5% v/v).
- Aloe Barbadensis Leaf Juice (0.5% 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
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78240-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 42 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ) 0.3 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 2.4 mL in 100 mL HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) 0.9 mL in 100 mL WATER (UNII: 059QF0KO0R) 24 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78240-001-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Lokahi Brewing Company LLC (122458275) Establishment Name Address ID/FEI Business Operations Lokahi Brewing Company LLC 122458275 manufacture(78240-001)