Label: MOISTURIZING HAND SANITIZER- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78548-5102-1, 78548-5102-3, 78548-5102-4 - Packager: Molecular GPS Enterprises dba Clayton Chemical
- 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 January 18, 2022
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to CFR Part333A and 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, ISO9001, and EN13485:
- 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.
- Glycerol (2.0% v/v).
- Lavender oil ((0.2% v/v).
- Guar Gum (0.025% wt/v).
- Glacial acetic acid (000% v/v)
- Hydrogen peroxide (0.15% v/v).
- Collagen (0.0003% wt/v).
- Purified 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
MOISTURIZING HAND SANITIZER
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78548-5102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 700 mL in 1000 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 20 mL in 1000 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 4.2 mL in 1000 mL WATER (UNII: 059QF0KO0R) 272.45 mL in 1000 mL LAVENDER OIL (UNII: ZBP1YXW0H8) 2 mL in 1000 mL ACETIC ACID (UNII: Q40Q9N063P) 0.1 mL in 1000 mL BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C) 1 mL in 1000 mL GUAR GUM (UNII: E89I1637KE) 0.25 mL in 1000 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78548-5102-1 59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 07/17/2020 2 NDC:78548-5102-3 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/17/2020 3 NDC:78548-5102-4 3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/17/2020 Labeler - Molecular GPS Enterprises dba Clayton Chemical (075329532) Registrant - Molecular GPS Enterprises dba Clayton Chemical (075329532) Establishment Name Address ID/FEI Business Operations Molecular GPS Enterprises dba Clayton Chemical 075329532 manufacture(78548-5102)
