Label: FRESH MED SOLUTION - glycerin, alcohol and glyceryl monostearate liquid
- NDC Code(s): 52257-1100-1, 52257-1100-2
- Packager: ATOMY CO LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Drug Facts
Glyceryl Stearate 1.000%
Keep out of Reach of Children
Keep out of reach of childrenif swallowed, get medical help or contact a Poison Control Center right away
Indication & Usage
Gently cleanse and dry area.
Apply liberally to affected area as needed.
Children under 6 months: ask a doctor
WarningsFor 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
Any area that is infected or reddened
Dosage & Administration
Temporarily protects and helps relieve chapped or cracked skin
Helps protect from the drying effects of wind and cold weather
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)
- INGREDIENTS AND APPEARANCE
FRESH MED SOLUTION
glycerin, alcohol, glyceryl monostearate liquid
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52257-1100 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 1.744 mL in 40 mL ALCOHOL (ALCOHOL) ALCOHOL 1.6 mL in 40 mL GLYCERYL MONOSTEARATE (GLYCERYL MONOSTEARATE) GLYCERYL MONOSTEARATE 0.4 mL in 40 mL Inactive Ingredients Ingredient Name Strength 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 Color white (white blue) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52257-1100-2 1 in 1 BOX 1 NDC:52257-1100-1 40 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/18/2011 Labeler - ATOMY CO LTD (631154601) Registrant - ATOMY CO LTD (631154601) Establishment Name Address ID/FEI Business Operations ATOMY CO LTD 631154601 relabel Establishment Name Address ID/FEI Business Operations KOLMAR KOREA CO LTD 687846360 manufacture