HAND SANITIZER WIPES- alcohol solution 
PDD Design LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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

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

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

15 wipes

Cool Wipes Safe Clean enriched with vitamins - Package Label

15 Wipes NDC: 77848-002-15

15 wipes

Cool Wipes Baby with Plantain Extract - Package Label

15 wipes NDC: 77848-003-15

15 wipes

HAND SANITIZER WIPES 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77848-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77848-003-1515 mL in 1 CARTON; Type 0: Not a Combination Product05/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/29/2020
HAND SANITIZER WIPES 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77848-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77848-001-1515 mL in 1 PACKET; Type 0: Not a Combination Product06/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/03/2020
HAND SANITIZER WIPES 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77848-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77848-002-1515 mL in 1 PACKET; Type 0: Not a Combination Product05/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/29/2020
Labeler - PDD Design LLC (065947601)

Revised: 12/2020
Document Id: b5b8b9f1-d9eb-aa3e-e053-2a95a90a551e
Set id: a6dea22c-12dd-0723-e053-2995a90aa1af
Version: 2
Effective Time: 20201205
 
PDD Design LLC