Label: KELLYS DELIGHT HAND SANITIZER (APPLE CIDER)- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79175-010-01, 79175-010-02, 79175-010-03, 79175-010-04, view more79175-010-05, 79175-010-06, 79175-010-07, 79175-010-08, 79175-010-09, 79175-010-10, 79175-010-11 - Packager: WACO BOTTLING 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 August 3, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only.
Flammable. Keep away from heat or flame.
Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive Ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
KELLYS DELIGHT HAND SANITIZER (APPLE CIDER)
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79175-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913) METHYL CINNAMATE (UNII: 533CV2ZCQL) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) LIMONENE, (+)- (UNII: GFD7C86Q1W) CARYOPHYLLENE (UNII: BHW853AU9H) METHYL DIHYDROJASMONATE, (-)-TRANS- (UNII: XM1C2C5MMN) .ALPHA.-ISOPROPYL-PHENETHYL ALCOHOL (UNII: N06AQ6J88Y) DIETHYL MALONATE (UNII: 53A58PA183) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79175-010-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 2 NDC:79175-010-02 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 3 NDC:79175-010-03 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 4 NDC:79175-010-04 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 5 NDC:79175-010-05 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 6 NDC:79175-010-06 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 7 NDC:79175-010-07 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 8 NDC:79175-010-08 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 9 NDC:79175-010-09 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 10 NDC:79175-010-10 18927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 11 NDC:79175-010-11 208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/03/2020 Labeler - WACO BOTTLING LLC (080331158) Establishment Name Address ID/FEI Business Operations WACO BOTTLING LLC 080331158 manufacture(79175-010)
