Safe and Silky Natural Hand Sanitizer: Package Insert and Label Information

SAFE AND SILKY NATURAL HAND SANITIZER- benzalkonium chloride 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.

Safe & Silky Natural 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 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

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

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55 Gallon Drum — Safe & Silky Natural Hand Sanitizer — Label

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330 Gallon Tote — Safe & Silky Natural Hand Sanitizer — Label

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1 Gallon Jug — Safe & Silky Natural Hand Sanitizer — Label

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2OZ Bottlel — Safe & Silky Fragrance Hand Sanitizer — Label

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4OZ Bottlel — Safe & Silky Fragrance Hand Sanitizer — Label

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8OZ Bottlel — Safe & Silky Fragrance Hand Sanitizer — Label

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5 Gallon Pail — Safe & Silky Fragrance Hand Sanitizer — Label

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SAFE AND SILKY NATURAL HAND SANITIZER
safe and silky fragrance hs lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78235-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE .13 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED
SOYBEAN OIL
PETROLATUM
PECTIN
XANTHAN GUM
GRAPEFRUIT SEED OIL
TRIBUTYL PHOSPHITE
METHYLPARABEN
PROPYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78235-010-01 3785 mL in 1 JUG None
2 NDC:78235-010-02 208175 mL in 1 DRUM None
3 NDC:78235-010-03 18927.1 mL in 1 CONTAINER None
4 NDC:78235-010-04 1249050 mL in 1 CONTAINER None
5 NDC:78235-010-05 1040875 mL in 1 CONTAINER None
6 NDC:78235-010-06 60 mL in 1 CONTAINER None
7 NDC:78235-010-07 118 mL in 1 CONTAINER None
8 NDC:78235-010-08 237 mL in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 10/06/2020
Labeler — CK Polymers LLC (079790285)
Establishment
Name Address ID/FEI Operations
CK Polymers LLC 079790285 manufacture (78235-010)

Revised: 10/2020 CK Polymers LLC

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