HYDRATING ANTI-BACTERIAL HAND SANITIZER- alcohol lotion

Hydrating Anti-Bacterial Hand Sanitizer by

Drug Labeling and Warnings

Hydrating Anti-Bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICAS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Use

• Hand sanitizer to help reduce bacteria on skin

Warnings

Flammable. Keep away from 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 rash appears and lasts

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

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product

Other information

• Store below 110°F (43°C)
• May discolor certain fabrics and surfaces

Inactive ingredients

water, glycerin, carbomer, triethanolamine

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

SHISEIDO
AMERICAS

Hydrating Anti-Bacterial
Hand Sanitizer

THE
BEAUTY OF HELPING
OTHERS

SERVING OUR
COMMUNITIES

Label donated by
Standwill Packaging

3.4 FL. OZ. (100 mL)

INGREDIENTS AND APPEARANCE

HYDRATING ANTI-BACTERIAL HAND SANITIZER 
alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-535
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-535-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
2	NDC: 58411-535-11	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
3	NDC: 58411-535-12	3785 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	part333E	04/01/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(58411-535) , ANALYSIS(58411-535)