SEVEN THREE HAND SANITIZER- alcohol antiseptic 70% gel

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

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Active ingredient:
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V), ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Seven Three Distilling Company, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- For handwashing to decrease bacteria on the skin - recommended for repeated use Stop use and ask a doctor if skin irritation develops. Antiseptic, Hand Sanitizer
Authorization status:
OTC monograph not final
Authorization number:
75219-7300-1

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SEVEN THREE HAND SANITIZER- alcohol antiseptic 70% gel

Seven Three Distilling Company, 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.

----------

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain

Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance

for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade

ingredients in the preparation of the product (percentage in final product formulation) consistent with

World Health Organization (WHO) recommendations:

a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an

aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in

27 CFR part 20.

b. Glycerol (1.45% v/v).

c. Hydrogen peroxide (0.125% v/v).

d. Sterile distilled water or boiled cold water.

e. Methacrylic Acid - Ethyl Acrylate Copolymer (5.5% v/v)

The firm does add other active or inactive ingredients. Different or additional ingredients may impact

the quality and potency of the product.

Active Ingredient(s)

Ethanol 70%. Purpose: Antiseptic

Hydrogen Peroxide <1%. Purpose: Antiseptic

Us e

For handwashing to decrease bacteria on the skin

recommended for repeated use

Warnings

For external use only - hands.

Flammable. Keep away from heat or flame.

When usting this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

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

away.

Warnings

for children under 6, use only under adult supervision

not recommended for infants

avoid contact with broken skin

When using this product keep out of eyes. In case of contact with eyes, flush thoroghly with water.

Avoid contact with broken skin.

Do not ingest or inhale.

Stop use and ask a doctor if skin irritation develops.

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

Center right away.

Stop use and ask a doctor if skin irritation develops.

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

away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For childres under 6, use only under adult supervision

Not recommended for infants

Other information

Do not store above 105°F

May discolor some fabrics

harmful to wood finishes and plastics

Inactive ingredients

water, glycerin, carbopol, lemongrass oil

Purpos e

Antiseptic, Hand Sanitizer

Package Label - Principal Display Panel

128 FL OZ (3785ML) 75219-7300-1

SEVEN THREE HAND SANITIZER

alcohol antiseptic 70% gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:75219 -730 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V) (HYDROGEN PEROXIDE -

UNII:BBX0 6 0 AN9 V)

HYDROGEN

PEROXIDE

0 .125 mL

in 10 0 mL

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

WEST INDIAN LEMO NGRASS O IL (UNII: 5BIA40 E9 ED)

0 .0 0 2 mL in 10 0 mL

METHACRYLIC ACID - ETHYL ACRYLATE CO PO LYMER ( 4 50 0 MPA.S) (UNII: T9 6 7IEU43C)

5.5 mL in 10 0 mL

GLYCERIN (UNII: PDC6 A3C0 OX)

1.45 mL in 10 0 mL

Seven Three Distilling Company, LLC

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:75219 -730 0 -1 378 5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /0 1/20 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 3/30 /20 20

Labeler -

Seven T hree Distilling Company, LLC (087822184)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Seven Three Distilling Co mpany, LLC

0 8 78 2218 4

ma nufa c ture (75219 -730 0 )

Revised: 2/2021

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