CALMING SKIN   - panthenol, glycerin and tocopherol lotion 
ATOMY 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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Drug Facts

Active ingredient
Vitamin E 0.500%
Glycerin    0.500%
Panthenol 0.500%

Purpose

Acne treatment and skin protectant

Keep out of Reach of Children

Stop use and ask a doctor if
too much skin irritation or sensitivity develops or increases.

Keep out of reach of children
if swallowed, get medical help or contact a Poison Control Center right away.

Indication & Usage

Directions
Clean the skin thoroughly before applying.
Cover the entire affected area with a thin layer 1 to 3 times daily.
Because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, use a sunscreen, and then follow directions in the sunscreen labeling.

Warnings

Warnings

For external use only.
Do not use on broken skin, on large areas of the body.
When using this product apply to affected areas only, avoid unnecessary sun exposure and use a sunscreen, do not use in or near the eyes, using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of th skin, only one drug should be used unless directed by a doctor.

Dosage & Administration


Uses
Treats acne. Dries up acne pimples. Helps prevent new acne pimples.

Inactive Ingredient

Houttuynia Cordata Extract, Foeniculum Vulgare(Fennel) Fruit Extract, Ocimum Basilicum(Basil) Flower/Leaf Extract, Chamomile Flower, Roman Extract, Lavandula Angustifolia(Lavender) Flower Extract, Rosmarinus Officinalis Leaf/Root Extract, Portulaca Oleracea Extract, Centella Asiatica Extract, Citrus Unshiu Fruit Oil, Macadamia Ternifolia Seed Oil, Hydrogenated Lecithin, Vitamin A Palmitate, Edetate Disodium, Phosphate

Calming skin

ATOMY Calming skin

Net WT. 4.39 FL OZ(130ml)

image of carton label



CALMING SKIN  
panthenol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PANTHENOL (PANTHENOL) PANTHENOL0.65 mL  in 130 mL
GLYCERIN (GLYCERIN) GLYCERIN0.65 mL  in 130 mL
TOCOPHEROL (TOCOPHEROL) TOCOPHEROL0.65 mL  in 130 mL
Inactive Ingredients
Ingredient NameStrength
ALTHAEA OFFICINALIS LEAF 
CHAMAEMELUM NOBILE FLOWER 
BITTER FENNEL 
HOUTTUYNIA CORDATA FLOWERING TOP 
LAVANDULA ANGUSTIFOLIA FLOWER 
OCIMUM BASILICUM FLOWERING TOP 
PURSLANE 
ROSEMARY 
CENTELLA ASIATICA 
HEXANEDIOL 
PHELLINUS LINTEUS MYCELIUM 
CERAMIDE 3 
CITRUS RETICULATA FRUIT OIL 
HYDROGENATED SOYBEAN LECITHIN 
MACADAMIA OIL 
VITAMIN A PALMITATE 
GLYCERYL MONOSTEARATE 
UBIDECARENONE 
EDETATE DISODIUM 
SODIUM ASCORBYL PHOSPHATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52257-1015-21 BOTTLE ( BOTTLE) in 1 BOXcontains a BOTTLE (52257-1015-1)
1NDC:52257-1015-1130 mL in 1 BOTTLEThis package is contained within the BOX (52257-1015-2)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/22/2011

Labeler - ATOMY CO LTD (631154601)
Registrant - ATOMY CO LTD (631154601)
Establishment
NameAddressID/FEIOperations
ATOMY CO LTD631154601relabel
Establishment
NameAddressID/FEIOperations
KOLMAR KOREA CO LTD687846360manufacture

Revised: 06/2011 ATOMY CO LTD