8 OZ HAND SANITIZER GEL EVERCARE LABS- 8oz/236.59ml 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.

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8oz/236.59ml 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:

  1. 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.
  2. Isopropyl Alcohol (1.00% v/v).
  3. Carbomer (0.30% v/v).
  4. Triethanolamine (0.15% v/v)
  5. Aloe Vera (0.01%v/v)
  6. 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.

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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

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

Other information

Inactive ingredients

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

Package Label - Principal Display Panel

8oz Gel Hand EverCare236.59 mL NDC: 75321-6008-4

8 OZ HAND SANITIZER GEL EVERCARE LABS 
8oz/236.59ml gel - evercare labs gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75321-6008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL165.61 mL  in 236.59 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.35 mL  in 236.59 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.02 mL  in 236.59 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) 2.37 mL  in 236.59 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.71 mL  in 236.59 mL
WATER (UNII: 059QF0KO0R) 67.52 mL  in 236.59 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75321-6008-4236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - SunBeam Laboratories LLC (105139335)
Establishment
NameAddressID/FEIBusiness Operations
SunBeam Laboratories LLC105139335manufacture(75321-6008)

Revised: 10/2020
Document Id: b376265a-f07a-599d-e053-2995a90a28f6
Set id: b3763182-242f-155a-e053-2995a90ab578
Version: 1
Effective Time: 20201001
 
SunBeam Laboratories LLC