Label: HAND SANITIZER- alcohol liquid
- NDC Code(s): 80078-001-03
- Packager: Nancy's Passions LLC
- 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 November 26, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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
-
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
50 mL NDC: 80078-001-03
Topical Spray Solution
Alcohol Antiseptic
Hand Sanitizer
80% Alcohol
Non-sterileThe image shows the front panel of the pouch. It is manufactured in California by me. The rear has the drug facts and pertinent information. Inside the pouch, there is the product that also has the appropriate label and all info (front and back). I am using a pouch as a security feature.
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80078-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.013 mL in 100 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) 0.005 mL in 100 mL LAVENDER OIL (UNII: ZBP1YXW0H8) 0.02 mL in 100 mL SPEARMINT OIL (UNII: C3M81465G5) 0.01 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 8.431 mL in 100 mL 2-AMINO-1,3-PROPANEDIOL (UNII: IC94L30J8M) 2.418 mL in 100 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 0.0278 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.581 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 28.5158 mL in 100 mL RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN) 0.013 mL in 100 mL VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW) 0.013 mL in 100 mL TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.022 mL in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 3.2833 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.332 mL in 100 mL SAGE OIL (UNII: U27K0H1H2O) 0.02 mL in 100 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.066 mL in 100 mL PANTHENOL (UNII: WV9CM0O67Z) 0.8165 mL in 100 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.022 mL in 100 mL DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.022 mL in 100 mL COCO GLUCOSIDE (UNII: ICS790225B) 0.017 mL in 100 mL SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) 0.004 mL in 100 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.173 mL in 100 mL LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) 0.0545 mL in 100 mL LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) 0.0545 mL in 100 mL ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13) 0.035 mL in 100 mL BETAINE (UNII: 3SCV180C9W) 0.026 mL in 100 mL WITCH HAZEL (UNII: 101I4J0U34) 0.01 mL in 100 mL CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60) 0.1 mL in 100 mL VANILLA PLANIFOLIA OIL (UNII: 0A3F415158) 0.06 mL in 100 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80078-001-03 1 in 1 POUCH 12/10/2020 1 50 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/26/2020 Labeler - Nancy's Passions LLC (080236251) Registrant - Nancy's Passions LLC (080236251) Establishment Name Address ID/FEI Business Operations Nancy's Passions LLC 080236251 manufacture(80078-001)