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NDC 28691-6000-06 GermiFree Antimicrobial Hand Gel 67.7 mL/100mL Details

GermiFree Antimicrobial Hand Gel 67.7 mL/100mL

GermiFree Antimicrobial Hand Gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaplast SAE. The primary component is ALCOHOL.

Product Information

NDC	28691-6000
Product ID	28691-6000_e113d642-53e9-48e7-9ed8-4eff4dd3ee5b
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	GermiFree Antimicrobial Hand Gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	67.7
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Pharmaplast SAE
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 28691-6000-06 (28691600006)

Pricing Information	N/A
NDC Package Code	28691-6000-6
Billing NDC	28691600006
Package	1000 mL in 1 BOTTLE (28691-6000-6)
Marketing Start Date	2020-03-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c2928bc6-b0f7-424e-87c9-0f701b7cf0c7 Details

Drug Facts

Active ingredient

Ethyl alcohol 60% w/w

Purpose

Antimicrobial

Use

hand sanitizer to help reduce microbes on the skin

Warnings

Flammable. Keep away from fire or flame

For external use only

When using this product, do not use in or near the eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours and continues

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• put enough gel in your palm to cover hands and rub hands together rapidly until dry

• children under 6 years of age should be supervised when using this product

Other information

• store below 110°F (43°C)

• may discolor certain fabrics or surfaces

Inactive ingredients

carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

SPL UNCLASSIFIED SECTION

Kill Germs up to 99.99% of most common germs that may cause illness

Distributed by:

Acme United Corporation

55 Walls Drive

Fairfield, CT 06824

1-800-835-2263

Made in Egypt

Packaging

INGREDIENTS AND APPEARANCE

GERMIFREE ANTIMICROBIAL HAND GEL

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:28691-6000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	67.7 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON (UNII: Z4152N8IUI)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:28691-6000-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2020
2	NDC:28691-6000-2	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2020
3	NDC:28691-6000-3	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2020
4	NDC:28691-6000-4	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2020
5	NDC:28691-6000-5	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2020
6	NDC:28691-6000-6	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/14/2020

Labeler - Pharmaplast SAE (644773319)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaplast SAE		644773319	manufacture(28691-6000)

Revised: 11/2020

Document Id: e113d642-53e9-48e7-9ed8-4eff4dd3ee5b

Set id: c2928bc6-b0f7-424e-87c9-0f701b7cf0c7

Version: 2

Effective Time: 20201107