3CE DRAWING LIP CHILLING- lanolin lipstick 
Nanda 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 INGREDIENT

Active Ingredient: Lanolin 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Mica, Hydrogenated Coco-Glycerides, Red 27 Lake (CI 45410), Red 7 Lake (CI 15850), Rhus Succedanea Fruit Wax, Stearic Acid, Iron Oxides(CI 77499), Triethylhexanoin, Hydrogenated Castor Oil, Acetylated Sucrose Distearate, Microcrystalline Wax, Butylparaben

PURPOSE

Purpose: Lip Protectant

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

KEEP OUT OF REACH OF CHILDREN

Keep away from reach of children

INSTRUCTIONS

INSTRUCTIONS: Pencil-type lipstick that glides on lips like a crayon.

Directions

Directions: Hold the pencil flat against the lip and apply by tracing your natural lip line, moving towards to fill in.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

3CE DRAWING LIP CHILLING 
lanolin lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lanolin (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) Lanolin0.02 g  in 1.1 g
Inactive Ingredients
Ingredient NameStrength
Mica (UNII: V8A1AW0880)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-111-021 in 1 CARTON08/01/2016
1NDC:60764-111-011.1 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075manufacture(60764-111)

Revised: 10/2016
Document Id: 3bcebd30-c36e-403c-9069-efdffd38c139
Set id: fdfd657d-9755-43f6-ab63-d9d270dba481
Version: 1
Effective Time: 20161013
 
Nanda Co., Ltd