ULTRA MASSAGECREAM- acetyl glucosamine cream 
PK Bio Co., Ltd.

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.

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ACTIVE INGREDIENTS

Acetyl Glucosamine

INACTIVE INGREDIENTS

Water, Glycerin, Zea Mays (Corn) Kernel Extract, Acetyl Glucosamine, Dimethyl Sulfone

PURPOSE

■ Involved in helping the production of hyaluronic acid Helps increase moisture in the skin

■ Care for damaged skin due to external irritation

WARNINGS

For external use only

When using this product

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis. 2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Pour a small amount into hands, spread evenly and rub into the body

Directions

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

ULTRA MASSAGECREAM 
acetyl glucosamine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81712-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
N-ACETYLGLUCOSAMINE (UNII: V956696549) (N-ACETYLGLUCOSAMINE - UNII:V956696549) N-ACETYLGLUCOSAMINE12 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81712-0001-160 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2021
Labeler - PK Bio Co., Ltd. (695816631)
Registrant - PK Bio Co., Ltd. (695816631)
Establishment
NameAddressID/FEIBusiness Operations
PK Bio Co., Ltd.695816631manufacture(81712-0001)

Revised: 3/2021
Document Id: beccdc9f-07ee-31d4-e053-2a95a90a23b3
Set id: beccdc9f-07ef-31d4-e053-2a95a90a23b3
Version: 1
Effective Time: 20210330
 
PK Bio Co., Ltd.