Smith Golden Rule Hand Sanitizer

Smith Golden Rule Hand Sanitizer by

Drug Labeling and Warnings

Smith Golden Rule Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dyno Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMITH GOLDEN RULE HAND SANITIZER- alcohol 80% spray 
Dyno Manufacturing

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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Smith Golden Rule Hand Sanitizer

Active Ingredient

Alcohol 80%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria on the skin 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

In children less than 2 months of age

On open skin wounds

When using this product

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

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.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

-Store between 15-30C (59-86F).

-Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Denatonium Benzoate, Glycerine, Hydrogen peroxide, Tertiary Butyl alcohol, Water

Smith Golden Rule Hand Sanitizer Spray

SMITH GOLDEN RULE HAND SANITIZER 
alcohol 80% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79532-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	94.4 mL  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79532-008-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/01/2020	03/01/2022

Labeler - Dyno Manufacturing (015718256)

Registrant - Dyno Manufacturing (015718256)

Revised: 12/2022

Document Id: f05c7b8d-d631-51db-e053-2a95a90afa52

34390-5

Set id: b467f78a-e1d1-2408-e053-2a95a90af045

Version: 2

Effective Time: 20221221