128OZ HAND SANITIZER GEL LEMONGRASS EVERCARE LABS- 128oz/3785.41ml gel lemongrass

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)
F) Lemongrass (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
Purpose

Antiseptic, Hand Sanitizer
Use

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

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

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

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, Lemongrass, Sterile distilled water or boiled cold water.
Package Label - Principal Display Panel

3785.41 mL NDC: 75321-7128-5

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75321-7128
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2649.79 mL in 3785.41 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)	5.68 mL in 3785.41 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.38 mL in 3785.41 mL
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)	0.38 mL in 3785.41 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	37.85 mL in 3785.41 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	11.36 mL in 3785.41 mL
WATER (UNII: 059QF0KO0R)	1079.98 mL in 3785.41 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 75321-7128-5	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - SunBeam Laboratories LLC (105139335)

Name	Address	ID/FEI	Business Operations
Establishment
SunBeam Laboratories LLC		105139335	manufacture(75321-7128)

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

128oz Hand Sanitizer Gel Lemongrass EverCare Labs by

Drug Labeling and Warnings

Drug Details [pdf]