Label: INTENSE CARE GALACTOMYCES FIRST ESSENCE- glycerin cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 13, 2013
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of haviong problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
INTENSE CARE GALACTOMYCES FIRST ESSENCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin 31 mg in 155 mL Inactive Ingredients Ingredient Name Strength Butylene Glycol (UNII: 3XUS85K0RA) Pentylene Glycol (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59078-003-01 155 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/01/2013 Labeler - TONYMOLY CO., LTD. (688216798) Registrant - TONYMOLY CO., LTD. (688216798) Establishment Name Address ID/FEI Business Operations TONYMOLY CO., LTD. 688216798 manufacture(59078-003)