HAND SANITIZING WIPES- benzalkonium chloride cloth

Hand Sanitizing Wipes by

Drug Labeling and Warnings

Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by BELLA BRANDS INC, Ningbo Riway Nonwovens Tech Co., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredient

Benzalkonium Chloride, 0.13%

Purpose

Antimicrobial Agent

Use

for cleaning hands and decreasing bacteria on the skin.

Warnings

- For external use only.

- Do not use if you are allergic to any of the ingredients.

- When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water.

- Stop use and consult a doctor if irritation or rash develops and continues for more than 72 hours.

- Keep out of reach of children. If swallowed, get medical help or visit a Poison Control Center right away.

Inactive Ingredients

C12-14 Alkyl Dimethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene Glycol, Aloe Vera Leaf Juice (Organic), Aqua.

Directions For Use

- Press dispensing pump to release product into hands, add water and rub thoroughly around both sides of hands and between fingers. Rinse off and towel dry.

- For adults and children 2 years and over.

- For children under 2 years of age, consult a doctor before use.

Directions

• - Tear open dispensing cap and remove entire lid from canister.
• - Locate wipe at center of the roll, twist corner to a point and thread through small opening in lid.
• - Replace lid and pull wipe up at an angle. Remaining wipes feed automatically.
• - Snap lid cap shut to retail moisture when finished.
  Adults and children 2 years and over
  Apply to hands, Allow skin to dry without wiping
  Children under 2 years, ask a doctor before use

SPL UNCLASSIFIED SECTION

Manufactured for Bella Brands Inc.
Aliso Viejo, California
By Ningbo Riway Daily Commodity Co Ltd.
Ningbo City, Zhejiang Province

PRINCIPAL DISPLAY PANEL - 500 Wipe Canister Label

PURIGEN™
Hand Sanitizing Wipes

• Kills 99.9% of Germs
• Clean Hands On-The-Go
• Safe for Sensitive Skin
• Made with Organic Aloe Vera

500
Wipes
17.5 x 17 cm

INGREDIENTS AND APPEARANCE

HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80994-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Propylene Glycol (UNII: 6DC9Q167V3)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80994-005-01	160 in 1 CANISTER	05/01/2020
1		0.0044 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 80994-005-02	500 in 1 CANISTER	05/01/2020
2		0.0044 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - BELLA BRANDS INC (034908755)

Establishment
Name	Address	ID/FEI	Business Operations
BELLA BRANDS INC		034908755	MANUFACTURE(80994-005)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Riway Nonwovens Tech Co., LTD.		540997562	MANUFACTURE(80994-005)