Label: ROOTSALLO TOOTHPASTE- calcium carbonate, alcloxa, aminocaproic acid, dibasic calcium phosphate dihydrate gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 82450-050-01, 82450-050-02 - Packager: rootsallo Qwell
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 30, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- Uses
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Warnings
(1) Do not swallow, gargle fully after using.
(2) If the use of this paste causes gingiva or oral cavity injury, please stop using and consult a doctor or a dentist.
(3) If childern under 6 years of age use, please apply a pea-sized amount each thime.
Do not swallow. Please use under the guidance of the guardian.
(4) If children under 6 years of age accidentally ingest large amounts of the paste, please consult a doctor or a dentist immediately.
(5) Keep out of reach of children under 6 years of age.
(6) This product contains sodium benzoate, which has mild irritation to the skin, eyes and mucosa. - KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Questions
- Inactive ingredients
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROOTSALLO TOOTHPASTE
calcium carbonate, alcloxa, aminocaproic acid, dibasic calcium phosphate dihydrate gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82450-050 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 10.30 g in 100 g ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA 0.05 g in 100 g Aminocaproic Acid (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) Aminocaproic Acid 0.05 g in 100 g DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE 0.30 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) Glycerin (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82450-050-02 1 in 1 CARTON 12/01/2021 1 NDC:82450-050-01 120 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/2021 Labeler - rootsallo Qwell (695495466) Registrant - rootsallo Qwell (695495466) Establishment Name Address ID/FEI Business Operations Woorilife&Health 694860803 manufacture(82450-050)
