WELLAGE POST PROCEDURE POINT CONCEALER- titanium dioxide cream

WELLAGE Post Procedure Point Concealer by

Drug Labeling and Warnings

WELLAGE Post Procedure Point Concealer by is a Otc medication manufactured, distributed, or labeled by HUGEL PHARMA CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

titanium dioxide

INACTIVE INGREDIENT

isopropyl myristate, mica candelilla wax, sorbitan olivate ceresin, dimethicone, lanolin, methicone, etc

PURPOSE

sun block, skin protectant

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

apply proper amount to the skin

WARNINGS

・Stop using the product when you have skin problems or the product disagrees with your skin
・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
・If the product gets into the eyes, don't rub but rinse with water.
・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WELLAGE POST PROCEDURE POINT CONCEALER 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69346-4001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69346-4001-1	4.8 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2014

Labeler - HUGEL PHARMA CO.,LTD (688400184)

Registrant - HUGEL PHARMA CO.,LTD (688400184)

Establishment
Name	Address	ID/FEI	Business Operations
HUGEL PHARMA CO.,LTD		688400184	manufacture(69346-4001)