DR. JAMES GEL (ETHANOL)- alcohol gel 
WOORILIFE&HEALTH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Woorilife&Health - Dr.James Gel

alcohol

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

antiseptic

Take moderate amount on hands and rub well to dry

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

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

Consult a dentist or doctor

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.

for external use only


label

DR. JAMES GEL (ETHANOL) 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73065-0005-1100 mL in 1 TUBE; Type 0: Not a Combination Product06/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/2020
Labeler - WOORILIFE&HEALTH (694860803)
Registrant - WOORILIFE&HEALTH (694860803)
Establishment
NameAddressID/FEIBusiness Operations
WOORILIFE&HEALTH694860803manufacture(73065-0005)

Revised: 6/2020
Document Id: a8f8876b-99b2-5223-e053-2a95a90a2fd2
Set id: a8f88761-bf7a-fc11-e053-2a95a90aa7ae
Version: 1
Effective Time: 20200626
 
WOORILIFE&HEALTH