NoTS LIP BALM by NoTS Co.,Ltd

NoTS LIP BALM by

Drug Labeling and Warnings

NoTS LIP BALM by is a Otc medication manufactured, distributed, or labeled by NoTS Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NOTS LIP BALM- dimethicone stick 
NoTS Co.,Ltd

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.

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ACTIVE INGREDIENT

Active Ingredient: Dimethicone 1.02%

INACTIVE INGREDIENT

Inactive Ingredients: Diisostearyl Malate, Ceresin, Petrolatum, Polybutene, Butyrospermum Parkii (Shea) Butter, C16-18 Hydroxyalkyl Hydroxydimerdilinoleyl Ether, Hydrogenated Polyisobutene, Octyldodecanol, Polyglyceryl-2 Triisostearate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyethylene, Phenoxyethanol, Tocopheryl Acetate, Microcrystalline Wax, BHT, Simmondsia Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Fruit Extract, Aloe ferox leaf extract

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. Discontinue use if the following abnormal situations occur. If you continue to use, it may worsen symptoms, consult a dermatologist etc. A) If sings of redness, skin swelling, itchy spots, irritation or rash etc appear B) If the above signs appear in the applied area by direct rays of the sun 2. Do not use over wounds, rashes, inflammations or other troubled areas. 3. Notice when maintaining and handling A) You must close the cap after using B) Keep out of reach of children C) Do not keep in the place of high or low temperature and in direct sunlight.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: Apply on dry, rough lips as needed.

DOSAGE & ADMINISTRATION

Dosage & administration: Apply adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

NOTS LIP BALM 
dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69716-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.03 g  in 3.2 g
Inactive Ingredients
Ingredient NameStrength
Ceresin (UNII: Q1LS2UJO3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69716-160-013.2 g in 1 CARTON; Type 0: Not a Combination Product02/01/201612/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/201612/01/2018
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
CNF CO.,LTD.689852175manufacture(69716-160)

Revised: 12/2019
 
NoTS Co.,Ltd