DURASHIELD ORIGINAL SCENT HAND SANITIZER- safe and silky fragrance hs lotion 
CK Polymers 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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DuraShield® Original Scent

DuraShield® Original Scent

Active Ingredients

Active Ingredients: Benzalkonium chloride 0.13%

Purpose

Purpose: 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 in children less than 2 months of age or an open skin wounds.

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

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

water, corn starch, soybean oil, petrolatum, pectin, xanthan gum, citricidal, tributyl phosphate, methyl paraben, propyl paraben, vitamin E acetate, white linen fragrance

55 Gallon Tote - DuraShield® Original Scent Hand Sanitizer - Label

image description

330 Gallon Tote - DuraShield® Original Scent Hand Sanitizer - Label

new-330

275 Gallon Tote - DuraShield® Original Scent - Label

new-275

2OZ Bottle - DuraShield® Original Scent Hand Sanitizer - Label

2oz Durashield

4OZ Bottle - DuraShield® Original Scent Hand Sanitizer - Label

4 OZ Durashield

8OZ Bottle - DuraShield® Original Scent Hand Sanitizer - Label

8 oz Durashield

DURASHIELD ORIGINAL SCENT HAND SANITIZER 
safe and silky fragrance hs lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78235-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED (UNII: QG4MW19XYX)  
SOYBEAN OIL (UNII: 241ATL177A)  
PETROLATUM (UNII: 4T6H12BN9U)  
PECTIN (UNII: 89NA02M4RX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
TRIBUTYL PHOSPHITE (UNII: 498030B4AD)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZYL BENZOATE (UNII: N863NB338G)  
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)  
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)  
.ALPHA.-ISOBUTYLPHENETHYL ALCOHOL (UNII: 2SBL0E1I0N)  
BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
METHYL-.ALPHA.-IONONE (UNII: QMK5X3FBG7)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
NEROL (UNII: 38G5P53250)  
GERANIOL (UNII: L837108USY)  
ISOAMYL SALICYLATE (UNII: M25E4ZMR0N)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78235-011-013780 mL in 1 JUG; Type 0: Not a Combination Product10/08/2020
2NDC:78235-011-02208190 mL in 1 DRUM; Type 0: Not a Combination Product10/08/2020
3NDC:78235-011-0318927.1 mL in 1 CONTAINER; Type 0: Not a Combination Product10/08/2020
4NDC:78235-011-041249190 mL in 1 CONTAINER; Type 0: Not a Combination Product10/08/2020
5NDC:78235-011-051040990 mL in 1 CONTAINER; Type 0: Not a Combination Product10/08/2020
6NDC:78235-011-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/2020
7NDC:78235-011-07120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/2020
8NDC:78235-011-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/08/2020
Labeler - CK Polymers LLC (079790285)
Establishment
NameAddressID/FEIBusiness Operations
CK Polymers LLC079790285manufacture(78235-011)

Revised: 4/2022
Document Id: 3945b000-e039-4b40-a865-61243ae42aa6
Set id: 47c64b60-8400-4e3d-a361-be3026a2374d
Version: 6
Effective Time: 20220420
 
CK Polymers LLC