KELLYS DELIGHT HAND SANITIZER (APPLE CIDER)- alcohol gel 
WACO BOTTLING 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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Active Ingredient

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

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 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.

Directions

•Wet hands.

•Briskly rub hands together until dry.

•Supervise children in the use of this product.

Other Information

•Store at 20-25C(68-77F)

•Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Fragrance (Parfum), Glycerin, lsopropyl Myristate, PEG-6 & AMP Acrylates I Vinyl lsodecanoate Crosspolymer, Tocopheryl Acetate.

Package Label - Principal Display Panel

Kellys Delight Apple Cider Hand Sanitizer

KELLYS DELIGHT HAND SANITIZER  (APPLE CIDER)
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79175-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79175-010-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
2NDC:79175-010-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
3NDC:79175-010-03236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
4NDC:79175-010-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
5NDC:79175-010-05500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
6NDC:79175-010-06946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
7NDC:79175-010-071000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
8NDC:79175-010-081893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
9NDC:79175-010-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
10NDC:79175-010-1018927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
11NDC:79175-010-11208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/03/2020
Labeler - WACO BOTTLING LLC (080331158)
Establishment
NameAddressID/FEIBusiness Operations
WACO BOTTLING LLC080331158manufacture(79175-010)

Revised: 8/2020
Document Id: 50c637ef-bb90-4c21-bd5b-5ab1baee28a1
Set id: 40b1f960-b06d-4c3b-93c4-6b9a031abc25
Version: 1
Effective Time: 20200803
 
WACO BOTTLING LLC