Label: REMEDY NUTRASHIELD- dimethicone lotion
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NDC Code(s):
53329-157-02,
53329-157-04,
53329-157-13,
53329-157-77, view more53329-157-96
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 17, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
aloe barbadensis leaf juice, ascorbic acid, ascorbyl palmitate, c12-c13 pareth-3, c12-c13 pareth-23, carthamus tinctorius seed oil, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis peel oil, citrus grandis peel oil, citrus tangerina peel oil, cyclopentasiloxane, diazolidinyl urea, dimethicone crosspolymer, dimethiconol,
divinyldimethicone/dimethicone copolymer, ethyl vanillin, glycine, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea fruit oil, olea europaea leaf extract, peg-8, peg/ppg-18/18 dimethicone, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, sodium chloride, tocopherol, water. - SPL UNCLASSIFIED SECTION
- Package Labels
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INGREDIENTS AND APPEARANCE
REMEDY NUTRASHIELD
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-157 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) SAFFLOWER OIL (UNII: 65UEH262IS) CHOLECALCIFEROL (UNII: 1C6V77QF41) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ORANGE OIL (UNII: AKN3KSD11B) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCINE (UNII: TE7660XO1C) METHYLPARABEN (UNII: A2I8C7HI9T) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ACETYLCYSTEINE (UNII: WYQ7N0BPYC) NIACINAMIDE (UNII: 25X51I8RD4) OLIVE OIL (UNII: 6UYK2W1W1E) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) VANILLIN (UNII: CHI530446X) WATER (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-157-13 59 mL in 1 TUBE; Type 0: Not a Combination Product 10/10/2018 12/06/2023 2 NDC:53329-157-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 10/10/2018 12/06/2023 3 NDC:53329-157-96 144 in 1 BOX 10/10/2018 03/31/2024 3 4 mL in 1 PACKET; Type 0: Not a Combination Product 4 NDC:53329-157-77 4 mL in 1 PACKET; Type 0: Not a Combination Product 06/01/2005 03/31/2024 5 NDC:53329-157-02 3 in 1 BAG 07/01/2021 5 NDC:53329-157-04 118 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2005 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)