HAND SANITIZER- alcohol solution

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Conopco, Inc. d/b/a/ Unilever, Apex International MFG, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 72% v/v

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria on the skin. 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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

ASK DOCTOR

Discontinue use and ask a doctor if irritation, redness or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Other information

• Store below 105°F (40.5°C)
• May discolor certain fabrics or surfaces
  

Inactive Ingredients

Water, Hydroxypropylcellulose, Glycerin (Vegetable), Pyrus Malus (Apple) Fruit Extract, Shea Butter Ethyl Esters, Argania Spinosa (Argan) Kernel Oil, Boswellia Serrata (Frankincense) Extract, Commiphora Myrrha (Myrrh) Resin Extract, Fragrance

PACKAGE LABEL

Shea Moisture®
Established 1912

HAND SANITIZER
w/Argan Oil

KILLS 99.99% OF GERMS

3.2 fl oz / 95 mL

Distributed by: Sundial Brands LLC,
11 Ranick Drive South, Amityville, NY 11701

Questions? Call us at 1-866-478-1925

Empty before Recycling

PLASTIC BOTTLE
how2recyle.info

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1743
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Hydroxypropyl Cellulose, Unspecified (UNII: 9XZ8H6N6OH)
Glycerin (UNII: PDC6A3C0OX)
Apple (UNII: B423VGH5S9)
Shea Butter (UNII: K49155WL9Y)
Argan Oil (UNII: 4V59G5UW9X)
Indian Frankincense (UNII: 4PW41QCO2M)
Myrrh (UNII: JC71GJ1F3L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1743-1	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020
2	NDC: 64942-1743-2	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/22/2020

Labeler - Conopco, Inc. d/b/a/ Unilever (001375088)

Registrant - Apex International MFG, Inc. (015226132)

Establishment
Name	Address	ID/FEI	Business Operations
Apex International MFG, Inc.		015226132	manufacture(64942-1743)