SKINFOOD CACAO HAND BALM by SKINFOOD CO.,LTD. / Seoul cosmetics co.,ltd Drug Facts

SKINFOOD CACAO HAND BALM by

Drug Labeling and Warnings

SKINFOOD CACAO HAND BALM by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO.,LTD., Seoul cosmetics co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKINFOOD CACAO HAND BALM HIGH MOIST TYPE- glycerin cream 
SKINFOOD 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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Drug Facts

Active ingredient

Active ingredient: GLYCERIN 35%

Inactive ingredients

Inactive ingredients:
Water, Cetearyl alcohol, Isopropyl Myristate, Cocoa butter, Bees Wax, Stearic Acid, Polymethyl silsesquioxane, Mineral Oil, Shea Butter, Glyceryl Stearate , Polysorbate 60, Methyl Paraben, Tocopheryl Acetate, Propyl Paraben, Triethanolamine, Cocoa powder, Phenoxyethanol, Benzophenone-3, Perfum

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:
For external use only.
Avoid contact with eyes.
Discontinue use if signs of irritation appear.
Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Helps prevent and temporarily protects chafed, chapped, or cracked skin
Helps prevent and protect from the drying effects of wind and cold weather

Directions

Apply as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SKINFOOD CACAO HAND BALM  HIGH MOIST TYPE
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-040
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	19.2 g  in 48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
COCOA (UNII: D9108TZ9KG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-040-01	48 g in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2011	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2011	11/01/2019

Labeler - SKINFOOD CO.,LTD. (690324173)

Registrant - SKINFOOD CO.,LTD. (690324173)

Establishment
Name	Address	ID/FEI	Business Operations
IPEERES COSMETICS CO., LTD.		687590526	manufacture(76214-040)

Revised: 12/2019

Document Id: 19c639e6-f28e-4396-8326-85cd87423865

34390-5

Set id: ff1956ca-32ea-4c89-9dd1-595b79de643b

Version: 3

Effective Time: 20191226

 

SKINFOOD CO.,LTD.