Label: HAND SANITIZER- isopropyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 74412-0001-2 - Packager: Meli LBC, Inc.
- 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 May 11, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This hand sanitizer is manufactured using only the listed United States Pharmacopoeia (USP) grade ingredients consistent with World Health Organization (WHO) recommendations.
No 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 sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74412-0001 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) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74412-0001-2 3785 mL in 1 JUG; Type 0: Not a Combination Product 05/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/12/2020 Labeler - Meli LBC, Inc. (122239373) Establishment Name Address ID/FEI Business Operations Meli LBC, Inc. 122239373 manufacture(74412-0001)