Drug Facts

Active Ingredients [s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

•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

in 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.
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

Glycerol, Hydrogen Peroxide, Purified Water USP, Cross Polymer Cellulose, Fragrance.

Alcohol Antiseptic 80%
Topical Solution
Non-sterile Solution

MANUFACTURED BY
SHAMAN BOTANICALS, LLC2405 Southwest Blvd.
Kansas City, MO 64108
AmericanShamanProducts.com
855-427-7386

Packaging

untitled

AMERICAN SHAMAN HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77551-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77551-001-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
2	NDC:77551-001-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
3	NDC:77551-001-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
4	NDC:77551-001-11	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/11/2020

Labeler - Cbd American Shaman, LLC (085803529)

Name	Address	ID/FEI	Business Operations
Establishment
Cbd American Shaman, LLC		085803529	manufacture(77551-001)

American ShamanTM Hand Sanitizer