DR. JAMES GEL (ETHANOL)- alcohol gel

Dr. James Gel (Ethanol) by

Drug Labeling and Warnings

Dr. James Gel (Ethanol) by is a Otc medication manufactured, distributed, or labeled by WOORILIFE&HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

alcohol

INACTIVE INGREDIENT

glycerin, triethanolamine, carbomer, lemon oil, aloe vera gel, hinoki oil, green tea extract, edta, water

PURPOSE

antiseptic

KEEP OUT OF REACH OF CHILDREN

Take moderate amount on hands and rub well to dry

INDICATIONS & USAGE

• Adults and children 2 years of age and older

Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or docter.

• Children under 6 years

To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.

• Children under 2 years

Consult a dentist or doctor

WARNINGS

1) Be careful not to swallow it, and rinse your mouth thoroughly after use.

2) If any abnormalities such as gum or mouth damage are caused by using this toothpaste, stop using the product and consult a doctor or dentist.

3) For children under 6 years of age, use a small amount of pea toothpaste per serving and use it under the supervision of a guardian to avoid sucking or swallowing.

4) If a child under 6 years of age swallows a large amount, consult a doctor or dentist immediately.

5) Keep out of reach of children under 6 years old.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. JAMES GEL (ETHANOL) 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73065-0005
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
EDETIC ACID (UNII: 9G34HU7RV0)
LEMON OIL (UNII: I9GRO824LL)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73065-0005-1	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/22/2020

Labeler - WOORILIFE&HEALTH (694860803)

Registrant - WOORILIFE&HEALTH (694860803)

Establishment
Name	Address	ID/FEI	Business Operations
WOORILIFE&HEALTH		694860803	manufacture(73065-0005)