Label: BLACK PAINT RUBAR- glycerin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70768-020-01, 70768-020-02 - Packager: ZEMNA COMPANY CO., Ltd
- 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.
Drug Label Information
Updated July 19, 2016
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings: 1. If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above. 2. Do not use the product on an open skin wound or on areas of eczema or infection. 3. Storage and handling instructions 1) Keep out of reach of children. 2) Avoid exposure to high or low temperatures or sun.
- How to use
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BLACK PAINT RUBAR
glycerin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70768-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin 13.5 g in 45 g Inactive Ingredients Ingredient Name Strength Butylene Glycol (UNII: 3XUS85K0RA) Dipropylene Glycol (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70768-020-02 1 in 1 CARTON 06/01/2016 1 NDC:70768-020-01 45 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2016 Labeler - ZEMNA COMPANY CO., Ltd (689846931) Registrant - ZEMNA COMPANY CO., Ltd (689846931) Establishment Name Address ID/FEI Business Operations ZEMNA COMPANY CO., Ltd 689846931 manufacture(70768-020)