Label: ULTRA MASSAGECREAM- acetyl glucosamine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81712-0001-1 - Packager: PK Bio Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated March 30, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTS
- PURPOSE
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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
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTRA MASSAGECREAM
acetyl glucosamine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81712-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength N-ACETYLGLUCOSAMINE (UNII: V956696549) (N-ACETYLGLUCOSAMINE - UNII:V956696549) N-ACETYLGLUCOSAMINE 12 g in 100 mL ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.04 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81712-0001-1 60 mL in 1 TUBE; Type 0: Not a Combination Product 03/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/31/2021 Labeler - PK Bio Co., Ltd. (695816631) Registrant - PK Bio Co., Ltd. (695816631) Establishment Name Address ID/FEI Business Operations PK Bio Co., Ltd. 695816631 manufacture(81712-0001)
