PUROMA HAND SANITIZER WIPE ALCOHOL FREE WITH FRAGRANCE- benzalkonium chloride liquid

PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance by

Drug Labeling and Warnings

PUROMA Hand Sanitizer Wipe Alcohol Free with Fragrance 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 productdo not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor ifirritation 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.

Other information

Store below 104°F (40°C).

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, Fragrance Lemon ORC2001060.

Product label

INGREDIENTS AND APPEARANCE

PUROMA HAND SANITIZER WIPE ALCOHOL FREE WITH FRAGRANCE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-017
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
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)
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80948-017-01	10 in 1 PACKAGE	04/24/2021	04/24/2021
1		66 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 80948-017-02	20 in 1 PACKAGE	04/24/2021	04/24/2021
2		132 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 80948-017-03	40 in 1 PACKAGE	04/24/2021	04/24/2021
3		264 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 80948-017-04	80 in 1 PACKAGE	04/24/2021	04/24/2021
4		528 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC: 80948-017-05	120 in 1 PACKAGE	04/24/2021	04/24/2021
5		792 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC: 80948-017-06	50 in 1 CANISTER	04/24/2021	04/24/2021
6		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
7	NDC: 80948-017-07	100 in 1 CANISTER	04/24/2021	04/24/2021
7		700 mL in 1 CANISTER; Type 0: Not a Combination Product
8	NDC: 80948-017-08	10 in 1 POUCH	10/19/2021
8		66 mL in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 80948-017-09	20 in 1 POUCH	11/19/2021
9		132 mL in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 80948-017-10	40 in 1 POUCH	10/19/2021
10		264 mL in 1 POUCH; Type 0: Not a Combination Product
11	NDC: 80948-017-11	80 in 1 CANISTER	10/19/2021
11		528 mL in 1 CANISTER; Type 0: Not a Combination Product
12	NDC: 80948-017-12	120 in 1 CANISTER	10/19/2021
12		792 mL in 1 CANISTER; Type 0: Not a Combination Product
13	NDC: 80948-017-13	50 in 1 CANISTER	10/19/2021
13		330 mL in 1 CANISTER; Type 0: Not a Combination Product
14	NDC: 80948-017-14	100 in 1 CANISTER	10/19/2021
14		660 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	03/05/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-017)