FRESH MED SOLUTION- glycerin, alcohol, glyceryl monostearate liquid 
ATOMY 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.

----------

Fresh Med Solution

ACTIVE INGREDIENT

Active ingredient: Glycerin 4.36%, Alcohol 4.000%, Glyceryl Stearate 1.000%

INACTIVE INGREDIENT

Inactive Ingredients:

Citrus unshiu fruit oil, Althaea officinalis leaf/root extract, Anthemis nobilis flower extract, Centella asiatica 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, Caprylic/capric glycerides, Macadamia ternifolia seed oil, Hydrogenated lecithin, Cetearyl alcohol, Sodium ascorbyl phosphate, Disodium EDTA

PURPOSE

PURPOSE: Skin Protectant

WARNINGS

Warnings:

For external use only
Avoid contact with eyes.
Do not apply to deep or puncture wounds.
If condition worsens, or does not improve within 7 days, consult a doctor.
Do not use
areas of eczema, skin inflammation, or after injury
When using this product
Keep out of eyes
Rinse with water to remove
Discontinue use if irritation or rash appear
Ask a doctor before use if you have
Irritated skin
Any area that is infected or reddened
Diabetes
Poor blood

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Directions

Directions:

Gently cleanse and dry area.
Apply liberally to affected area as needed.
Children under 6 months: ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

FRESH MED SOLUTION 
glycerin, alcohol, glyceryl monostearate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.744 g  in 40 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1.6 g  in 40 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) (GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) GLYCERYL MONOSTEARATE0.4 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
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)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
MACADAMIA OIL (UNII: 515610SU8C)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52257-1100-21 in 1 BOX07/18/201112/01/2017
1NDC:52257-1100-140 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/18/201112/01/2017
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIBusiness Operations
ATOMY CO., LTD.631154601manufacture(52257-1100)

Revised: 12/2018
 
ATOMY CO., LTD.