Drug Facts

Active ingredient

Ethyl Alcohol 75% V/V

Purpose

Antimicrobial.

Uses

Hand Sanitizer to help reduce bacteria on skin.

Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.
For external use only.
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

Inactive ingredients

Water,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate, PEG-12 Dimethicone (300 CST)

Other information

Store below 110°F (43°C).
May discolor certain fabrics or surfaces.

Product label

image description

PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80948-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO-CAPRYLATE (UNII: 4828G836N6)
GLYCERYL OLEATE (UNII: 4PC054V79P)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80948-012-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2021
2	NDC:80948-012-02	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2021
3	NDC:80948-012-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2021
4	NDC:80948-012-04	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2021
5	NDC:80948-012-05	220 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/06/2021
6	NDC:80948-012-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2021
7	NDC:80948-012-07	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2021
8	NDC:80948-012-08	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2021
9	NDC:80948-012-09	5000 mL in 1 CAN; Type 0: Not a Combination Product	04/06/2021
10	NDC:80948-012-10	50000 mL in 1 CAN; Type 0: Not a Combination Product	04/06/2021
11	NDC:80948-012-11	200000 mL in 1 CAN; Type 0: Not a Combination Product	04/06/2021
12	NDC:80948-012-12	70 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	03/10/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Name	Address	ID/FEI	Business Operations
Establishment
ZENITH MICRO CONTROL		915625571	manufacture(80948-012)