HEROES HAND SANITIZER GEL- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Gold Eagle Co.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Hand sanitizer to help reduce bacteria that potentially can cause disease.
Authorization status:
OTC monograph not final
Authorization number:
78007-115-23, 78007-115-24

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HEROES HAND SANITIZER GEL- alcohol gel

Gold Eagle Co.

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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HEROES'

Hand Sanitizer Gel

Drug Facts

Active Ingredient[s]

Ethanol 72% v/v

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame. Do not use

on children less than 2 months of age

on open skin wounds

in or near fire

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes

thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30C (59-86F)

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

Inactive Ingredients

Water, Carbomer, Aloe barbadensis leaf, Tocopherol acetate, Siloxane polyalkyleneoxide copolymer,

Aminomethyl propanol

Uses Pharmaceutical Grade Alcohol

TM

Natural Scent

Keeps Hands Feeling Soft

MADE IN USA

DO NOT AIR SHIP

©2020 Gold Eagle Co.

Gold Eagle Co.

4400 S. Kildare

Chicago, IL 60632

(800) 367-3245

heroeshandsanitizingrub.com

Packaging

HEROES HAND SANITIZER GEL

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:78 0 0 7-115

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

72 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

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

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:78 0 0 7-115-

443.6 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

11/15/20 20

2

NDC:78 0 0 7-115-

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

11/15/20 20

Gold Eagle Co.

2

Pro duc t

11/15/20 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

11/15/20 20

Labeler -

Gold Eagle Co. (005123211)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Go ld Eagle Co .

0 0 5123211

ma nufa c ture (78 0 0 7-115)

Revised: 11/2020

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