CALMING SKIN - panthenol, glycerin, 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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Calming skin

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

Inactive Ingredients:

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

PURPOSE

PURPOSE: Skin Protectant

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

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

Directions

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CALMING SKIN  
panthenol, glycerin, tocopherol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.65 g  in 130 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.65 g  in 130 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.65 g  in 130 mL
Inactive Ingredients
Ingredient NameStrength
ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
BITTER FENNEL (UNII: J5W36Y5WG8)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
ROSEMARY (UNII: IJ67X351P9)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PHELLINUS LINTEUS WHOLE (UNII: YVO92B1UCA)  
CERAMIDE 3 (UNII: 4370DF050B)  
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
MACADAMIA OIL (UNII: 515610SU8C)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
UBIDECARENONE (UNII: EJ27X76M46)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52257-1110-21 in 1 BOX07/18/201112/01/2017
1NDC:52257-1110-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/18/201112/01/2017
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIBusiness Operations
ATOMY CO., LTD.631154601manufacture(52257-1110)

Revised: 12/2018
 
ATOMY CO., LTD.