ISLEAF SHINE SMOOTH LIP GLAZE RED- mineral oil liquid

isLeaf Shine Smooth Lip Glaze Red by

Drug Labeling and Warnings

isLeaf Shine Smooth Lip Glaze Red by is a Otc medication manufactured, distributed, or labeled by C3 Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

mineral oil

INACTIVE INGREDIENT

polybutene, lauryl alcohol, etc

PURPOSE

skin protectant

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Open the cap, press the button to put suitable amount on the applicator and apply evenly. Keep in a place away from direct sunlight with the cap closed after use

WARNINGS

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISLEAF SHINE SMOOTH LIP GLAZE RED 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70818-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)	2 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70818-011-01	2.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product	08/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/08/2017

Labeler - C3 Co., Ltd. (689846633)

Registrant - C3 Co., Ltd. (689846633)

Establishment
Name	Address	ID/FEI	Business Operations
C3 Co., Ltd.		689846633	label(70818-011) , pack(70818-011) , manufacture(70818-011)