Label: 3CE DRAWING LIP PEN MAYHAP- titanium dioxide lipstick
-
Contains inactivated NDC Code(s)
NDC Code(s): 60764-106-01, 60764-106-02 - Packager: Nanda Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 13, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive Ingredients: Red 27 Lake (CI 45410), Hydrogenated Coco-Glycerides, Rhus Succedanea Fruit Wax, Stearic Acid, Mica, Hydrogenated Castor Oil, Triethylhexanoin, Yellow 6 Lake (CI 15985), Acetylated Sucrose Distearate, Red 7 Lake (CI 15850), Lanolin, Microcrystalline Wax, Red 6 Lake (CI 15850), Butylparaben
- PURPOSE
-
CAUTION
CAUTION: 1. If following problems occur upon using the product, stop use immediately; further use may worsen the symptoms. Consult with a dermatologist if necessary. 1) Red spots, swelling, itchiness, irritation, or any other irregularities. 2) If applied area shows above symptoms when exposed to direct sunlight. 2. Do not use on areas with skin conditions such as open wound, eczema, or any skin disease. 3. Notes on storage and handling 1) Always put the lid back on after use 2) Keep away from reach of children 3) Keep away from high/low temperature or direct sunlight
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
3CE DRAWING LIP PEN MAYHAP
titanium dioxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60764-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 0.26 g in 1.1 g Inactive Ingredients Ingredient Name Strength Stearic Acid (UNII: 4ELV7Z65AP) Mica (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60764-106-02 1 in 1 CARTON 08/01/2016 1 NDC:60764-106-01 1.1 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2016 Labeler - Nanda Co., Ltd (557816075) Registrant - Nanda Co., Ltd (557816075) Establishment Name Address ID/FEI Business Operations Nanda Co., Ltd 557816075 manufacture(60764-106)
