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NDC 50254-0585-18 High Five Hand Sanitizer 0.62 mL/mL Details

High Five Hand Sanitizer 0.62 mL/mL

High Five Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Beaver Research Company. The primary component is ALCOHOL.

Product Information

NDC	50254-0585
Product ID	50254-585_1d1d2abf-54f0-42f6-86e9-41d231ffc564
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	High Five Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.62
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	Beaver Research Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50254-0585-18 (50254058518)

Pricing Information	N/A
NDC Package Code	50254-585-18
Billing NDC	50254058518
Package	50 mL in 1 BOTTLE, PLASTIC (50254-585-18)
Marketing Start Date	2020-01-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d11c53b5-a807-4a10-9a6d-fcf29269030b Details

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

FLAMMABLE, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, PEG-10 acrylate, perfluorohexylethyl acrylate copolymer, propylene glycol, fragrance

High Five Hand Sanitizer 6585

High Five Hand Sanitizer 65

INGREDIENTS AND APPEARANCE

HIGH FIVE HAND SANITIZER

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50254-585
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50254-585-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2020
2	NDC:50254-585-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2020
3	NDC:50254-585-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/07/2020

Labeler - Beaver Research Company (044960466)

Registrant - ABC Compounding Co., Inc. (003284353)

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(50254-585)

Revised: 1/2020

Document Id: 1d1d2abf-54f0-42f6-86e9-41d231ffc564

Set id: d11c53b5-a807-4a10-9a6d-fcf29269030b

Version: 1

Effective Time: 20200107