CARE 1- hand sanitizer gel 
Lauree 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.

----------

Care1 2oz OTC Coconut Lemongrass and Lavender

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) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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 80% 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

glycerin, coconut, aloe, propanediol, hydroxyproppyl cellulose, cymbopogon citratus leaf, purified water USP, tert-butyl alcohol 59ml

Package Label - Principal Display Panel

59ml Coconut lemongrass59 mL NDC:78975-506-01 59ml Lavender

59 mL NDC:78975-507-02

CARE 1 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78975-506
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 10 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.125 mL  in 100 mL
2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ) 0.125 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
COCONUT (UNII: 3RT3536DHY) 0.5 mL  in 100 mL
CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5) 0.5 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78975-506-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/06/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/06/2020
CARE 1 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78975-507
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL47 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ) 0.125 mL  in 100 mL
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 10 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.125 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.5 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78975-507-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/06/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/06/2020
Labeler - Lauree LLC (102938225)
Registrant - Care 1 (066368393)
Establishment
NameAddressID/FEIBusiness Operations
Lauree LLC102938225manufacture(78975-506, 78975-507)

Revised: 11/2020
Document Id: b377e803-d446-6c10-e053-2995a90ad1e9
Set id: b377ff21-609d-1559-e053-2a95a90ace40
Version: 1
Effective Time: 20201106
 
Lauree LLC