KELLYS DELIGHT HAND SANITIZER (CANDY CANE)- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
WACO BOTTLING LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Authorization status:
OTC monograph not final
Authorization number:
79175-013-01, 79175-013-02, 79175-013-03, 79175-013-04, 79175-013-05, 79175-013-06, 79175-013-07, 79175-013-08, 79175-013-09, 79175-013-10, 79175-013-11

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KELLYS DELIGHT HAND SANITIZER (CANDY CANE)- 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.

----------

Active Ingredient

Ethyl Alcohol 70% v/v.

Purpos e

Antiseptic

Us e

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, Glycerin, Isopropyl Myristate, PEG-6 & AMP Acrylates/Vinyl Isodecanoate Crosspolymer,

Tocopheryl Acetate, Fragrance.

Package Label - Principal Display Panel

KELLYS DELIGHT HAND SANITIZER (CANDY CANE)

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:79 175-0 13

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

70 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PO LYETHYLENE GLYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)

ACRYLATES/VINYL ISO DECANO ATE CRO SSPO LYMER ( 10 0 0 0 MPA.S NEUTRALIZED AT 0 .5%) (UNII:

2N8 MDB79 NA)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

MENTHA ARVENSIS FLO WER O IL (UNII: Q129 Z1W6 Y2)

WACO BOTTLING LLC

ETHYL VANILLIN (UNII: YC9 ST449 YJ)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:79 175-0 13-

59 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

2

NDC:79 175-0 13-

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

3

NDC:79 175-0 13-

236 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

4

NDC:79 175-0 13-

473 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

5

NDC:79 175-0 13-

50 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

6

NDC:79 175-0 13-

9 46 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

7

NDC:79 175-0 13-

10 0 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

8

NDC:79 175-0 13-

18 9 3 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

9

NDC:79 175-0 13-

378 5 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

10

NDC:79 175-0 13-

18 9 27 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

11

NDC:79 175-0 13-

20 8 19 8 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 3/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 8 /0 3/20 20

Labeler -

WACO BOT T LING LLC (080331158)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

WACO BOTTLING LLC

0 8 0 331158

ma nufa c ture (79 175-0 13)

Revised: 8/2020

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