SANITIZING WIPES- hand sanitizer cloth

SANITIZING WIPES by

Drug Labeling and Warnings

SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by Big Time Products, Llc, Cangzhou Juyuan Sanitary Prducts Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.45% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Avoid exposure to the sun.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.







Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.







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

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• thoroughly wipe skin as desired
• allow to dry without wiping
• discard wipe after use, do not flush

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

aloe extract, citric acid, glycerin, propylene glycol, purified water USP.

Package Label - Principal Display Panel

100 Wipes in 1 Pail NDC: 80748-529-03

INGREDIENTS AND APPEARANCE

SANITIZING WIPES 
hand sanitizer cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80748-529
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.45 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80748-529-03	600 g in 1 PAIL; Type 0: Not a Combination Product	10/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/08/2020

Labeler - Big Time Products, Llc (119031495)

Registrant - Big Time Products, Llc (119031495)

Establishment
Name	Address	ID/FEI	Business Operations
Cangzhou Juyuan Sanitary Prducts Co., Ltd		526891925	manufacture(80748-529)