SAFE AND SILKY NATURAL 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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Safe & Silky Natural Hand Sanitizer

Safe & Silky Fragrance Hand Sanitizer

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 - Safe & Silky Fragrance Hand Sanitizer - Label

Original Label:

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Revised Label:

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330 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label

og-330

new-330

1 Gallon Jug - Safe & Silky Fragrance Hand Sanitizer - Label

og-1

275 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label

new-275

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5 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label

og-5

new-5

2OZ Bottle - Safe & Silky Fragrance Hand Sanitizer - Label

2oz Durashield

4OZ Bottle - Safe & Silky Fragrance Hand Sanitizer - Label

4 OZ Durashield

8OZ Bottle - Safe & Silky Fragrance Hand Sanitizer - Label

8 oz Durashield

SAFE AND SILKY NATURAL HAND SANITIZER 
safe and silky fragrance hs lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78235-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 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:78235-009-013780 mL in 1 JUG; Type 0: Not a Combination Product10/08/2020
2NDC:78235-009-02208190 mL in 1 DRUM; Type 0: Not a Combination Product10/08/2020
3NDC:78235-009-0318927.1 mL in 1 CONTAINER; Type 0: Not a Combination Product10/08/2020
4NDC:78235-009-041249190 mL in 1 CONTAINER; Type 0: Not a Combination Product10/08/2020
5NDC:78235-009-051040990 mL in 1 CONTAINER; 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(78235-009)

Revised: 10/2020
Document Id: 3f9a2158-0926-4b66-b020-0e1a232e307d
Set id: ae3fbbf0-6be2-4b02-8398-b58124b6b205
Version: 3
Effective Time: 20201021
 
CK Polymers LLC