Hydra Extra ConcentrateSerum: Package Insert and Label Information

HYDRA EXTRA CONCENTRATESERUM- adenosine and niacinamide liquid
In This Morning

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.

Niacinamide, Adenosine

Water, Glycerin, Butylene Glycol, Crithmum Maritimum Callus Culture Filtrate, etc.

Helps brighten the skin and reduce skin wrinkles.

keep out or reach of the children

Take an adequate amount of this product and evenly spread on the skin.

1. Discontinue use, if any of the following abnormal symptoms
occur after using the product. If you continue to use the
product, your symptoms can get worse. Please consult a
dermatologist.
1) If symptoms such as red spots, swelling, itching or irritation appear while
using the product
2) If the above symptoms appear when the skin is exposed to direct sunlight
after using the product
2. Do not use on wounds, and areas affected by eczema and
dermatitis
3. Precautions for storage and handling
1) Always recap after use.
2) Keep out of reach of infants and children.
3) Do not store at high or low temperatures, and in direct sunlight.
4. Avoid contact with the eyes.
— If you are very sensitive to a sticking plaster or a wet compress, use with
caution or discontinue use
— Limited to Whitening Concentrate Treatment Mask products.
— Fine grains can be felt due to CELTOSOMEā„¢ Crithmum Maritimum ST (Limited
to Hydra Extra Concentrate products.)
5. The SPF of this product was measured according to the
method of Cosmmedics Europe and its PA according to the
method of the Japan Cosmetic Industry Association (JCIA).
(Limited to Protective Base Sunscreen products for dry skin)
6. The SPF of this product was measured according to the
International SPF Test Method and its PA according to the
method of the Japan Cosmetic Industry Association (JCIA).
(Limited to Protective Base Sunscreen products for oily skin)
7. The SPF and PA of this product were measured according
to the methods proposed by the Regulations of Functional
Cosmetic Evaluation. (Limited to BB cream.)
8. Do not use on children under the age of 3 because this
product contains salicylic acids and salts.
(Limited to Purifying Sebum Relief Spot products.)
If this product causes any abnormal symptoms,
you can exchange it or be compensated for damages in
accordance with the consumer dispute settlement regulation
notified by the Fair Trade Commission.
This product was made by COSMAX
which has been approved to comply with
CGMP (Current Good Manufacturing Practice) regulations.

for external use only

1
(click image for full-size original)

HYDRA EXTRA CONCENTRATESERUM niacinamide, adenosine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71217-0004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENOSINE (ADENOSINE) ADENOSINE 0.04 g in 100 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
BUTYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71217-0004-1 30 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/08/2017
Labeler — In This Morning (694519423)
Registrant — In This Morning (694519423)
Establishment
Name Address ID/FEI Operations
In This Morning 694519423 label (71217-0004), pack (71217-0004), manufacture (71217-0004)

Revised: 02/2017 In This Morning

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