MOTHERS PROMISE HAND CLEAN GEL SOFT- alcohol gel

Mothers Promise Hand Clean Gel Soft by

Drug Labeling and Warnings

Mothers Promise Hand Clean Gel Soft by is a Otc medication manufactured, distributed, or labeled by ENS KOREA Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

alcohol 62%

INACTIVE INGREDIENT

Water
Glycerin
Propylene Glycol
Carbomer
Camellia Sinensis Leaf Extract
Aloe Barbadensis Leaf Extract
Sodium Hyaluronate
Triethanolamine
Citrus Limon (Lemon) Fruit Oil

PURPOSE

for hand washing to decrease bacteria on skin recommeded for repeated use

WARNINGS

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children.

INDICATIONS & USAGE

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 product

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOTHERS PROMISE HAND CLEAN GEL SOFT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73391-0016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73391-0016-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/04/2020

Labeler - ENS KOREA Co Ltd (688223124)

Registrant - ENS KOREA Co Ltd (688223124)

Establishment
Name	Address	ID/FEI	Business Operations
ENS KOREA Co Ltd		688223124	manufacture(73391-0016)