Calming Skin

Dosage form: lotion
Ingredients: PANTHENOL 0.65mL in 130mL, GLYCERIN 0.65mL in 130mL, TOCOPHEROL 0.65mL in 130mL
Labeler: ATOMY CO LTD
NDC Code: 52257-1110

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.

Calming skin

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

Althaea officinalis leaf/root extract, Anthemis nobilis flower extract, Foeniculum vulgare(fennel) fruit extract, Houttuynia cordata extract, Lavandula angustifolia(lavender) flower extract, Ocimum basilicum(basil) flower/leaf extract, Portulaca oleracea extract, Rosmarinus officinalis(rosemary) leaf extract, Centella asiatica extract, 1,2-Hexanediol, Phellinus linteus extract, Ceramide 3, Citrus unshiu fruit oil, Hydrogenated lecithin, Macadamia ternifolia seed oil, Retinyl palmitate, Glyceryl stearate, Ubiquinone, Disodium EDTA, Sodium ascorbyl phosphate

Calming skin

ATOMY Calming skin

Net WT. 4.39 FL OZ(130ml)

CALMING SKIN  
panthenol, glycerin, tocopherol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1110
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 
ALTHAEA OFFICINALIS ROOT 
CHAMAEMELUM NOBILE FLOWER 
BITTER FENNEL 
HOUTTUYNIA CORDATA FLOWERING TOP 
LAVANDULA ANGUSTIFOLIA FLOWER 
OCIMUM BASILICUM FLOWERING TOP 
PORTULACA OLERACEA WHOLE 
ROSEMARY 
CENTELLA ASIATICA 
1,2-HEXANEDIOL 
PHELLINUS LINTEUS WHOLE 
CERAMIDE 3 
CITRUS RETICULATA FRUIT OIL 
HYDROGENATED SOYBEAN LECITHIN 
MACADAMIA OIL 
VITAMIN A PALMITATE 
GLYCERYL MONOSTEARATE 
UBIDECARENONE 
EDETATE DISODIUM 
SODIUM ASCORBYL PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:52257-1110-21 BOTTLE (BOTTLE) in 1 BOX
1NDC:52257-1110-1130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/18/2011
Labeler - ATOMY CO LTD (631154601)
Registrant - ATOMY CO LTD (631154601)
Establishment
NameAddressID/FEIOperations
ATOMY CO LTD631154601relabel
Establishment
NameAddressID/FEIOperations
KOLMAR KOREA CO LTD687846360manufacture

Revised: 07/2011
 
ATOMY CO LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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