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.

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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, TERT-BUTYL ALCOHOL, purified water USP, HYDROXYPROPYL CELLULOSE, 1,2-PROPANEDIOL, ALOE

1000 ml Care1 Citrus

1000 ml Citrus

1000 ml Care1 Coconut Lemongrass

1000 ml Coconut Lemongrass

3785 ml Care1 Citrus

3785 ml Citrus

3785 ml Care1 Coconut Lemongrass

3785 ml Coconut Lemongrass

CARE 1 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78975-501
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
CITRUS FRUIT (UNII: XDK00Z8012) 1 mL  in 100 mL
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 10 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ) 80 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.125 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78975-501-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
CARE 1 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78975-502
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
CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5) 0.5 mL  in 100 mL
COCONUT (UNII: 3RT3536DHY) 0.5 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 10 mL  in 100 mL
2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ) 0.125 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78975-502-023785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
CARE 1 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78975-503
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
CITRUS FRUIT (UNII: XDK00Z8012) 1 mL  in 100 mL
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 10 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ) 80 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.125 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78975-503-031000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
CARE 1 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78975-504
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
CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5) 0.5 mL  in 100 mL
COCONUT (UNII: 3RT3536DHY) 0.5 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) 10 mL  in 100 mL
2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ) 0.125 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78975-504-041000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - LAUREE LLC (102938225)
Registrant - Care 1 (066368393)
Establishment
NameAddressID/FEIBusiness Operations
Lauree LLC102938225manufacture(78975-501, 78975-502, 78975-503, 78975-504)

Revised: 9/2020
Document Id: af9f4b84-4f2e-8ec7-e053-2a95a90a5929
Set id: af9f1db2-d4f7-2d5e-e053-2a95a90a7db1
Version: 4
Effective Time: 20200918
 
LAUREE LLC