GoodHands Hand Sanitizer Cool Rain

GoodHands Hand Sanitizer Cool Rain by

Drug Labeling and Warnings

GoodHands Hand Sanitizer Cool Rain by is a Otc medication manufactured, distributed, or labeled by SYMN Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GOODHANDS HAND SANITIZER COOL RAIN- alcohol gel 
SYMN Industries, 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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GoodHands Hand Sanitizer Cool Rain

Drug Facts

Active Ingredient

Alcohol 62% v/v

Purpose

Antiseptic

Uses

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

• for children less than 2 months of age
• on open skin wounds

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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store between 15-30C (59-85F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerin, Tocopheryl Acetate, Isopropyl Myristate, Propylene Glycol, Aminomethyl Propanol, Carbomer, Denatonium Benzoate, t-Butyl Alcohol, Fragrance

Company Information

Distributed by

SYMN Industries, LLC

21021 Heron Way

Lakeville, MN 55044

(888) 771 9065

GoodHandsUSA.com

Product Packaging - 946 mL

GoodHands

Clean solutions made with heart by good hands.

Hand Sanitizer

Cool Rain

62% - ALCOHOL

Vitamin E moisturizer leaves hands feeling smooth.

MADE IN USA

32 FL OZ (946 ML)

GOODHANDS HAND SANITIZER COOL RAIN 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74617-005
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
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74617-005-03	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/23/2020	11/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/23/2020	11/30/2022

Labeler - SYMN Industries, LLC (068971843)

Revised: 8/2021

Document Id: c977e8ae-4812-241b-e053-2a95a90a4329

34390-5

Set id: b45112f2-fe1c-a03e-e053-2995a90a7a7a

Version: 2

Effective Time: 20210813