Label: DR.EL GUM CARE TOOTH- precipitated calcium carbonate, dibasic calcium phosphate, aluminium chlorohydroxy allantoinate, aminocaproic acid paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 72440-107-01 - Packager: Dr. EL CO., LTD.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated September 25, 2019
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- Official Label (Printer Friendly)
- ACTIVE 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 physician
Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2 years: Ask a dentist or physician
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WARNINGS
(1) Do not swallow and rinse mouth thoroughly after use
(2) If you experience any problems with your gums or mouth during use,
discontinue use and consult your doctor.
(3) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.
(4) Consult a physician or dentist immediately if a child under 6 years old has
swallowed large quantities.
(5) Keep out of the reach of children under 6 years of age. - INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR.EL GUM CARE TOOTH
precipitated calcium carbonate, dibasic calcium phosphate, aluminium chlorohydroxy allantoinate, aminocaproic acid paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72440-107 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 0.1 g in 100 g CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 30 g in 100 g ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA 0.1 g in 100 g AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72440-107-01 120 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2019 Labeler - Dr. EL CO., LTD. (694771074) Registrant - Dr. EL CO., LTD. (694771074) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO.,LTD 557810721 manufacture(72440-107) Establishment Name Address ID/FEI Business Operations Dr. EL CO., LTD. 694771074 label(72440-107)
