Label: HAE YAN TOOTH- precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate paste
- 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 May 29, 2020
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
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
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
INGREDIENTS AND APPEARANCE
HAE YAN TOOTH
precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate paste
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73065-0004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID 0.09 g in 100 g DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE 0.09 g in 100 g CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 37 g in 100 g ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA 0.09 g in 100 g Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) LEVOMENTHOL (UNII: BZ1R15MTK7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73065-0004-1 130 g in 1 TUBE; Type 0: Not a Combination Product 05/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/25/2020 Labeler - WOORILIFE&HEALTH (694860803) Registrant - WOORILIFE&HEALTH (694860803) Establishment Name Address ID/FEI Business Operations WOORILIFE&HEALTH 694860803 manufacture(73065-0004)