HAND SANITIZER WIPES- alcohol solution

Hand Sanitizer Wipes by

Drug Labeling and Warnings

Hand Sanitizer Wipes by is a Otc medication manufactured, distributed, or labeled by PDD Design LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.1% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Kill germs and remove dirt

Warnings

For external use only.

Do not use

if you are allergic to any of ingredients

WHEN USING

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

STOP USE

Stop use and ask a doctor if irritation or rash develops and continuous for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Adults and children 3 years and over

Children under 3 years ask a doctor before use

Wipe with wipes and let dry

Other information

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

Cool Wipes Baby with Plantain Extract - Inactive Ingredients

Water, Glycerin, Propylene glycol, Plantago Major Leaf, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Ethylparaben, Cetrimonium Bromide, Citric Acid, Parfum

Cool Wipes Safe Clean enriched with vitamins - Inactive ingredients

Water, Glycerin, Propylene glycol, Tocopheryl acetate, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Panthenol, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Citric Acid, Parfum, Limonene, Citral

Cool Wipes Safe Clean enriched with plantain extract

Water, Glycerin, Propylene glycol, Plantago Major Leaf, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Ethylparaben, Cetrimonium Bromide, Citric Acid, Parfum

Cool Wipes Safe Clean enriched with plantain extract - Package Label

15 Wipes NDC: 77848-001-15

Cool Wipes Safe Clean enriched with vitamins - Package Label

15 Wipes NDC: 77848-002-15

Cool Wipes Baby with Plantain Extract - Package Label

15 wipes NDC: 77848-003-15

INGREDIENTS AND APPEARANCE

HAND SANITIZER WIPES 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77848-003
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
ETHYLPARABEN (UNII: 14255EXE39)
CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
2-NITROPROPANE (UNII: GKV234L2QH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77848-003-15	15 mL in 1 CARTON; Type 0: Not a Combination Product	05/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/29/2020

HAND SANITIZER WIPES 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77848-001
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
ETHYLPARABEN (UNII: 14255EXE39)
CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77848-001-15	15 mL in 1 PACKET; Type 0: Not a Combination Product	06/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/03/2020

HAND SANITIZER WIPES 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77848-002
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)
ETHYLPARABEN (UNII: 14255EXE39)
CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
2-NITROPROPANE (UNII: GKV234L2QH)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PANTHENOL (UNII: WV9CM0O67Z)
CITRAL (UNII: T7EU0O9VPP)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77848-002-15	15 mL in 1 PACKET; Type 0: Not a Combination Product	05/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/29/2020

Labeler - PDD Design LLC (065947601)