WELLGATE ANTI-BACTERIAL HAND SANITIZER- ethyl alcohol gel

Wellgate Anti-bacterial Hand Sanitizer by

Drug Labeling and Warnings

Wellgate Anti-bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Church & Dwight UK Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Ethyl Alcohol 70%. v/v

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses Hand sanitizer to help reduce bacteria. For use when soap and water are not available.

WARNINGS

Warnings

For external use only-hands.

Flammable. Keep away from heat and flame.

Do not use

• on 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.

STOP USE

Stop use and ask doctor if irritation 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.

DOSAGE & ADMINISTRATION

Directions

• To open, pull up on top of cap.
• Place enough product on hands to cover all surfaces.
• Rub hands together until dry.
• Keep lid closed after use.
• Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER SAFETY INFORMATION

Other information

• Store between 15-30ºC (59-86ºF)
• Avoid freezing and excessive heat above 40ºC (104ºF)
• May discolor certain fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients acrylates copolymer, aminomethylpropanol, water

QUESTIONS

Questions or Comments? Call us at 1-800-952-5080 M-F 9am-5pm ET

PRINCIPAL DISPLAY PANEL

Wellgate™

Gateway to Wellness™

Anti-bacterial

Hand Sanitizer

NET WT 8.5 FL OZ (250 ml)

INGREDIENTS AND APPEARANCE

WELLGATE ANTI-BACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-912
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-912-85	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2020

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight UK Limited		216138610	manufacture(10237-912)