Label: MOUSTURIZING GLOVES AND SOCKS (butyrospermum parkii(shea butter), simmondsia chinensis- jojoba seed oil, aloe barbadensis leaf extract liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71149-0001-1 - Packager: Clean Sense
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated December 28, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight4. Use as avoiding eye areas.
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Moisturizing Socks
1. Rinse feet thoroughly and completely dry them to remove any moisture.
2. Insert feet in the moisturizing socks and make sure the contents of the liquid are inside.
3. While wearing the moisturizing socks, massage feet to absorb all the liquid.
4. After 20 to 30 minutes, remove moisturizing socks and massage in the remaining liquid for long-lasting hydration.
Moisturizing Gloves
1. Wash hands thoroughly and completely dry them to remove any moisture.
2. Open and put hands in the hand moisturizing treatment and make sure the contents of the liquid makeup is inside.
3. While wearing the hand moisturizing treatment, massage them to thoroughly absorb all the moisture.
4. After 20-30 minutes remove the hand moisturizing treatment and softly pat down the remaining contents for better absorption. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOUSTURIZING GLOVES AND SOCKS
butyrospermum parkii(shea butter), simmondsia chinensis (jojoba) seed oil, aloe barbadensis leaf extract liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71149-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JOJOBA OIL (UNII: 724GKU717M) (JOJOBA OIL - UNII:724GKU717M) JOJOBA OIL 0.01 g in 100 g ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF 1 g in 100 g SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER 3.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) UREA (UNII: 8W8T17847W) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71149-0001-1 6 g in 1 POUCH; Type 0: Not a Combination Product 12/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/2016 Labeler - Clean Sense (687301630) Registrant - Clean Sense (687301630) Establishment Name Address ID/FEI Business Operations Clean Sense 687301630 manufacture(71149-0001)
