Label: SAFE AND SILKY NATURAL HAND SANITIZER- safe and silky fragrance hs lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 78235-009-01, 78235-009-02, 78235-009-03, 78235-009-04, view more78235-009-05 - Packager: CK Polymers LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 21, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Safe & Silky Fragrance 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.
- 55 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label
- 330 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label
- 1 Gallon Jug - Safe & Silky Fragrance Hand Sanitizer - Label
- 275 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label
- 5 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label
- 2OZ Bottle - Safe & Silky Fragrance Hand Sanitizer - Label
- 4OZ Bottle - Safe & Silky Fragrance Hand Sanitizer - Label
- 8OZ Bottle - Safe & Silky Fragrance Hand Sanitizer - Label
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INGREDIENTS AND APPEARANCE
SAFE AND SILKY NATURAL HAND SANITIZER
safe and silky fragrance hs lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78235-009 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) 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:78235-009-01 3780 mL in 1 JUG; Type 0: Not a Combination Product 10/08/2020 2 NDC:78235-009-02 208190 mL in 1 DRUM; Type 0: Not a Combination Product 10/08/2020 3 NDC:78235-009-03 18927.1 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/08/2020 4 NDC:78235-009-04 1249190 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/08/2020 5 NDC:78235-009-05 1040990 mL in 1 CONTAINER; 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(78235-009)