PUROMA by ZENITH MICRO CONTROL PUROMA- alcohol gel

PUROMA by

Drug Labeling and Warnings

PUROMA by is a Otc medication manufactured, distributed, or labeled by ZENITH MICRO CONTROL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol  70% V/V

Purpose

Antiseptic.

Warnings

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

Uses

Hand Sanitizer to help reduce bacteria on skin.

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.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Other information

• Store below 110°F (430°C)
• May discolor certain fabrics or surfaces

Inactive Ingredients

WATER, ISOPROPYL ALCOHOL ,GLYCERIN, ISOPROPYL MYRISTATE,ALPHA.-TOCOPHEROL ACETATE, CARBOMER HOMOPOLYMER , CAPRYLYL GLYCOL,AMINOMETHYLPROPANOL, ALOE VERA LEAF, PROPYLENE GLYCOL,COCO-CAPRYLATE , FRAGRANCE.

Product label

INGREDIENTS AND APPEARANCE

PUROMA 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO-CAPRYLATE (UNII: 4828G836N6)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80948-002-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2020
2	NDC: 80948-002-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2020
3	NDC: 80948-002-03	50 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	12/20/2020
4	NDC: 80948-002-04	100 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	12/20/2020
5	NDC: 80948-002-05	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2020
6	NDC: 80948-002-06	320 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2020
7	NDC: 80948-002-07	503 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2020
8	NDC: 80948-002-08	5000 mL in 1 CAN; Type 0: Not a Combination Product	12/20/2020
9	NDC: 80948-002-09	50000 mL in 1 CAN; Type 0: Not a Combination Product	12/20/2020
10	NDC: 80948-002-10	200000 mL in 1 DRUM; Type 0: Not a Combination Product	12/20/2020
11	NDC: 80948-002-11	12 in 1 PACKAGE	10/21/2021
11		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 80948-002-12	6 in 1 PACKAGE	10/21/2021
12		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 80948-002-13	4 in 1 PACKAGE	10/21/2021
13		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 80948-002-14	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021
15	NDC: 80948-002-15	488 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021
16	NDC: 80948-002-16	2 in 1 PACKAGE	10/21/2021
16		488 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 80948-002-17	947 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	12/20/2020

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-002)