Your browser does not support JavaScript! FRESH MED SOLUTION (GLYCERIN, ALCOHOL, GLYCERYL MONOSTEARATE) LIQUID [ATOMY CO LTD]
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FRESH MED SOLUTION (glycerin, alcohol, glyceryl monostearate) liquid
[ATOMY CO LTD]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active Ingredient

Glycerin                 4.36%

Alcohol                  4.000%

Glyceryl Stearate    1.000%

Purpose

Skin Protectant

Keep out of Reach of Children

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Indication & Usage

Directions

Gently cleanse and dry area.

Apply liberally to affected area as needed.

Children under 6 months: ask a doctor

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

Dosage & Administration

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Inactive Ingredient

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

Fresh Med Solution

ATOMY Fresh Med Solution

Net WT. 1.3 FL OZ(40ml)

image of carton label

FRESH MED SOLUTION 
glycerin, alcohol, glyceryl monostearate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52257-1100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN1.744 mL  in 40 mL
ALCOHOL (ALCOHOL) ALCOHOL1.6 mL  in 40 mL
GLYCERYL MONOSTEARATE (GLYCERYL MONOSTEARATE) GLYCERYL MONOSTEARATE0.4 mL  in 40 mL
Inactive Ingredients
Ingredient NameStrength
CITRUS RETICULATA FRUIT OIL 
ALTHAEA OFFICINALIS LEAF 
CHAMAEMELUM NOBILE FLOWER 
CENTELLA ASIATICA 
BITTER FENNEL 
HOUTTUYNIA CORDATA FLOWERING TOP 
LAVANDULA ANGUSTIFOLIA FLOWER 
OCIMUM BASILICUM FLOWERING TOP 
PORTULACA OLERACEA WHOLE 
ROSEMARY 
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES 
MACADAMIA OIL 
HYDROGENATED SOYBEAN LECITHIN 
CETOSTEARYL ALCOHOL 
SODIUM ASCORBYL PHOSPHATE 
EDETATE DISODIUM 
ALTHAEA OFFICINALIS ROOT 
Product Characteristics
Colorwhite (white blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52257-1100-21 in 1 BOX
1NDC:52257-1100-140 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/18/2011
Labeler - ATOMY CO LTD (631154601)
Registrant - ATOMY CO LTD (631154601)
Establishment
NameAddressID/FEIBusiness Operations
ATOMY CO LTD631154601relabel
Establishment
NameAddressID/FEIBusiness Operations
KOLMAR KOREA CO LTD687846360manufacture

Revised: 7/2011
 
ATOMY CO LTD

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