Label: PANION AND BF HAND SANITIZER- alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 78279-001-18, 78279-001-23, 78279-001-28, 78279-001-30, view more78279-001-32, 78279-001-35, 78279-001-49, 78279-001-99 - Packager: PANION & BF BIOTECH 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 July 1, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
-
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
- In children less than 2 months of age
- On open skin woundsWhen 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.
- Directions
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
PANION AND BF HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78279-001 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) O-CYMEN-5-OL (UNII: H41B6Q1I9L) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78279-001-18 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 2 NDC:78279-001-49 225 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 3 NDC:78279-001-99 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 4 NDC:78279-001-23 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 5 NDC:78279-001-35 360 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 6 NDC:78279-001-28 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 7 NDC:78279-001-30 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 8 NDC:78279-001-32 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/30/2020 Labeler - PANION & BF BIOTECH INC. (656381605) Establishment Name Address ID/FEI Business Operations PANION & BF BIOTECH INC. 656381605 manufacture(78279-001)
