PUROMA HAND SANITIZER WIPE ALCOHOL FREE- benzalkonium chloride cloth

PUROMA Hand Sanitizer Wipe Alcohol Free by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Uses

Hand Sanitizer to help reduce bacteria on skin.

Warnings

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

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pull out one sheet from the pack. Clean hands or affected area.

Discard wipes in trash receptacle after use.

Do not flush.

Close lid after each used to keep wipes fresh.

Inactive ingredients

Aqua, Coco Glucoside, Caprylyl Glycol, Cetrimonium Chloride, Behetrimonium Chloride, Decyl Glucoside, Peg-7 Glyceril Cocoate, Glyceril Oleate, Glycerin, Phenoxyethanol, Methylisothiozolinone, Methylchloro Isothiozolinone, Betain, Aloevera Leaf, Polysorbate 20 , Propylene glycol.

Other information

Store below 104°F (40°C)

Product label

INGREDIENTS AND APPEARANCE

PUROMA HAND SANITIZER WIPE ALCOHOL FREE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	130 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BETAINE (UNII: 3SCV180C9W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80948-011-01	10 in 1 PACKAGE	03/12/2021
1		66 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 80948-011-02	20 in 1 PACKAGE	03/12/2021
2		132 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 80948-011-03	40 in 1 PACKAGE	03/12/2021
3		264 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 80948-011-04	80 in 1 PACKAGE	03/12/2021
4		528 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC: 80948-011-05	120 in 1 PACKAGE	03/12/2021
5		792 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC: 80948-011-06	50 in 1 CANISTER	03/12/2021
6		350 mL in 1 CANISTER; Type 0: Not a Combination Product
7	NDC: 80948-011-07	100 in 1 CANISTER	03/12/2021
7		700 mL in 1 CANISTER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	03/12/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-011)