Label: GRAY SALT TOOTH- precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice
- NDC Code(s): 73242-0106-1
- Packager: DONG IL PHARMS CO.,LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated August 19, 2020
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
1. Keep it at room temperature in a classified container.
2. Cover and store at room temperature.
3. Store in a not moisture and cool place.
4. Air may come out during use of this product, but there is no problem with its weight.
1. Be careful not to swallow. Rinse mouth thoroughly after use
2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.
3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.
4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.
5. Keep out of the reach of children under 6 years of age.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
GRAY SALT TOOTH
precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73242-0106 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 38 g in 100 g ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA 0.05 g in 100 g AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID 0.05 g in 100 g CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 0.06 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:73242-0106-1 100 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2020 Labeler - DONG IL PHARMS CO.,LTD (557810721) Registrant - DONG IL PHARMS CO.,LTD (557810721) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(73242-0106)