Standard Hand Sanitizer by COSMETIC DEVELOPMENT LABS, LLC Standard Hand Sanitizer

Standard Hand Sanitizer by

Drug Labeling and Warnings

Standard Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by COSMETIC DEVELOPMENT LABS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STANDARD HAND SANITIZER- ethyl alcohol gel 
COSMETIC DEVELOPMENT LABS, 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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Standard Hand Sanitizer

Hand Sanitizer

Ethyl Alcohol, 62% v/v

Antiseptic

Uses

Sanitizer to reduce bacteria on the skin that could cause disease

Recommended for repeated use

Warnings

Flammable. Keep away from sources of heat, fire or flame.
For external use only.
When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or redness develops and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Dispense enough sanitizer to cover desired areas

Rub product into skin until dry

Children under 6 years of age should be supervised when using this product

Water, Aminomethyl Propanol, Carbomer, Methyl Gluceth-20

Store at a temperature below 110ºF (43ºC)

May discolor certain fabrics or surfaces

STANDARD HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74106-747
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.25 mL  in 100 mL
METHYL GLUCETH-20 (UNII: J3QD0LD11P)	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74106-747-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

Labeler - COSMETIC DEVELOPMENT LABS, LLC (010628265)

Registrant - COSMETIC DEVELOPMENT LABS, LLC (010628265)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC DEVELOPMENT LABS, LLC		010628265	manufacture(74106-747)

Revised: 4/2020

Document Id: a1df6bfa-7cd5-f1b3-e053-2995a90ac11d

34390-5

Set id: a1df6bfa-7cd4-f1b3-e053-2995a90ac11d

Version: 1

Effective Time: 20200401

 

COSMETIC DEVELOPMENT LABS, LLC