Hae Yan Tooth: Package Insert and Label Information

HAE YAN TOOTH- aminocaproic acid, dibasic calcium phosphate dihydrate, calcium carbonate and alcloxa paste
WOORILIFE&HEALTH

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.

precipitated calcium carbonate, aminocaproic acid, aluminium chlorohydrin allantoinate, dibasic calcium phosphate hydrate

d-sorbitol solution, glycerin, silica, roasted salt, xanthan gum, carboxymethylcellulose sodium, sodium lauryl sulfate, grapefruit seed extract, sodium saccharin, xylitol, l-menthol, green tea extract, propolis extract, glycyrrhiza extract, mulberry root extract, peppermint oil, purified water

aids in the prevention of dental cavities.

keep out of reach of the children

  • 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.

for external use only

label
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMINOCAPROIC ACID (AMINOCAPROIC ACID) AMINOCAPROIC ACID 0.09 g in 100 g
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (ANHYDROUS DIBASIC CALCIUM PHOSPHATE) DIBASIC CALCIUM PHOSPHATE DIHYDRATE 0.09 g in 100 g
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 37 g in 100 g
ALCLOXA (ALCLOXA) ALCLOXA 0.09 g in 100 g
Inactive Ingredients
Ingredient Name Strength
XYLITOL
LEVOMENTHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73065-0004-1 130 g in 1 TUBE None
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 Operations
WOORILIFE&HEALTH 694860803 manufacture (73065-0004)

Revised: 05/2020 WOORILIFE&HEALTH

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