SANITIZING WIPES- hand sanitizer cloth

Sanitizing Wipes by

Drug Labeling and Warnings

Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Ivy Rose Inc., Jiangsu Terra Medical Technology Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium chloride>=0.1%, Antimicrobial agent

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

For external use only.

Do not use

if you are allergic to any of the ingredients.

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 develops and continues for more than 72 hours.

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

• Adults and children 2 years and over.
• Apply to hands allow to dry without wiping.

Other information

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

Inactive ingredients

Water(aqua), Didecyl dimethy ammonium chloride, T5(Glycerin), T3(Aloe), T6(VE), Tributyl phosphate, Citric acid, Alcohol.

Package Label - Principal Display Panel

30 Individually Packed Wipes in 1 BOX NDC: 79247-812-01

Package Label - Principal Display Panel

20 Wipes in 1 BOX NDC: 79247-812-02

Package Label - Principal Display Panel

50 Wipes in 1 BOX NDC: 79247-812-03

Package Label - Principal Display Panel

80 Wipes in 1 BOX NDC: 79247-812-04

INGREDIENTS AND APPEARANCE

SANITIZING WIPES 
hand sanitizer cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79247-812
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.1 g  in 100 g
ALOE (UNII: V5VD430YW9)	0.0025 g  in 100 g
WATER (UNII: 059QF0KO0R)	94.915 g  in 100 g
ALCOHOL (UNII: 3K9958V90M)	4.7 g  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8)	0.0025 g  in 100 g
TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5)	0.01 g  in 100 g
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)	0.16 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.01 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79247-812-01	183 g in 1 BOX; Type 0: Not a Combination Product	08/12/2020
2	NDC: 79247-812-02	122 g in 1 BOX; Type 0: Not a Combination Product	08/12/2020
3	NDC: 79247-812-03	338 g in 1 BOX; Type 0: Not a Combination Product	08/12/2020
4	NDC: 79247-812-04	540 g in 1 BOX; Type 0: Not a Combination Product	08/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/12/2020

Labeler - Ivy Rose Inc. (037401255)

Registrant - Ivy Rose Inc. (037401255)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Terra Medical Technology Co. Ltd.		421340473	manufacture(79247-812)