Safe & Silky Natural Hand Sanitizer

Safe and Silky Natural Hand Sanitizer by

Drug Labeling and Warnings

Safe and Silky Natural Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CK Polymers LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Flammable. Keep away from heat or flame.

Do not use in children less than 2 months of age or on open skin wounds.

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

Questions

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

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

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

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

SAFE AND SILKY NATURAL HAND SANITIZER 
safe and silky fragrance hs lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78235-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.13 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78235-007-01	3790 mL in 1 JUG; Type 0: Not a Combination Product	10/06/2020
2	NDC: 78235-007-02	208190 mL in 1 DRUM; Type 0: Not a Combination Product	10/06/2020
3	NDC: 78235-007-03	18930 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020
4	NDC: 78235-007-04	1249190 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/06/2020	04/28/2022

Labeler - CK Polymers LLC (079790285)

Establishment
Name	Address	ID/FEI	Business Operations
CK Polymers LLC		079790285	manufacture(78235-007)

Revised: 4/2022

Document Id: d16bbad3-df02-4b75-a91c-69d4f99e561e

34390-5

Set id: 43a2c2f3-8930-44ab-a9e8-2e6ebd2f5f53

Version: 2

Effective Time: 20220428