WELLAGE WRINKLE REDUCED VIALS: Package Insert and Label Information

WELLAGE WRINKLE REDUCED VIALS — glycerin concentrate
HUGEL PHARMA CO.,LTD

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.

glycerin

water, betaine, carbomer, arginine, sodium hyaluronate, malt ext, cetyl alcohol, stearic acid, etc

sun block, skin protectant

keep out of reach of the children

apply proper amount to the skin

・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.

for external use only

package label
(click image for full-size original)
WELLAGE WRINKLE REDUCED VIALS
glycerin concentrate
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69346-5001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 7 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BETAINE
ARGININE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69346-5001-1 7 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/22/2015
Labeler — HUGEL PHARMA CO.,LTD (688400184)
Registrant — HUGEL PHARMA CO.,LTD (688400184)
Establishment
Name Address ID/FEI Operations
HUGEL PHARMA CO.,LTD 688400184 manufacture (69346-5001)

Revised: 01/2015 HUGEL PHARMA CO.,LTD

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