DURASHIELD ORIGINAL SCENT HAND SANITIZER- safe and silky fragrance hs lotion

DuraShield Original Scent Hand Sanitizer by

Drug Labeling and Warnings

DuraShield Original Scent Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CK Polymers LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

275 Gallon Tote - DuraShield® Original Scent - Label

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

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

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

INGREDIENTS AND APPEARANCE

DURASHIELD ORIGINAL SCENT HAND SANITIZER 
safe and silky fragrance hs lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78235-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78235-011-01	3780 mL in 1 JUG; Type 0: Not a Combination Product	10/08/2020
2	NDC: 78235-011-02	208190 mL in 1 DRUM; Type 0: Not a Combination Product	10/08/2020
3	NDC: 78235-011-03	18927.1 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/08/2020
4	NDC: 78235-011-04	1249190 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/08/2020
5	NDC: 78235-011-05	1040990 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/08/2020
6	NDC: 78235-011-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2020
7	NDC: 78235-011-07	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2020
8	NDC: 78235-011-08	240 mL in 1 BOTTLE; 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 - CK Polymers LLC (079790285)

Establishment
Name	Address	ID/FEI	Business Operations
CK Polymers LLC		079790285	manufacture(78235-011)