Label: DR. JAMES GEL (ETHANOL)- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73065-0005-1 - Packager: WOORILIFE&HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 26, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. JAMES GEL (ETHANOL)
alcohol gelProduct 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)