128OZ HAND SANITIZER GEL EVERCARE LABS- 128oz/3785.41ml gel- evercare labs gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
SunBeam Laboratories LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Authorization status:
OTC monograph not final
Authorization number:
75321-6128-4

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128OZ HAND SANITIZER GEL EVERCARE LABS- 128oz/3785.41ml gel- evercare labs gel

SunBeam Laboratories 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.

----------

128oz/3785.41ml Gel - EverCare Labs

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) Isopropyl Alcohol (1.00% v/v).

C) Carbomer (0.30% v/v).

D) Triethanolamine (0.15% v/v)

E) Aloe Vera (0.01%v/v)

Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients.

Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpos e

Antiseptic, Hand Sanitizer

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 children less than 2 months of age

on open skin wounds

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.

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

Isopropyl Alcohol, Carbomer, Triethanolamine, Aloe Vera, Sterile distilled water or boiled cold

water.

Package Label - Principal Display Panel

3785.41 mL NDC: 75321-6128-4

128OZ HAND SANITIZER GEL EVERCARE LABS

128oz/3785.4 1ml gel- evercare labs gel

SunBeam Laboratories LLC

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:75321-6 128

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

26 49 .79 mL in 378 5.41 mL

Inactive Ingredients

Ingredient Name

Stre ng th

TRO LAMINE (UNII: 9 O3K9 3S3TK)

5.6 8 mL in 378 5.41 mL

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

0 .38 mL in 378 5.41 mL

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

37.8 5 mL in 378 5.41 mL

CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E)

11.36 mL in 378 5.41 mL

WATER (UNII: 0 59 QF0 KO0 R)

10 8 0 .36 mL in 378 5.41 mL

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:75321-6 128 -

378 5.41 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/30 /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 -

SunBeam Laboratories LLC (105139335)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SunBeam Labo rato ries LLC

10 5139 335

ma nufa c ture (75321-6 128 )

Revised: 11/2020

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