Label: FLEXITOL HAPPY LITTLE BODIES ECZEMA RELIEF- oatmeal cream
- NDC Code(s): 43251-4927-1, 43251-4927-2
- Packager: LaCorium Health USA Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 6, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days.
- Directions
- Other Information
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Inactive ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, calendula officinalis flower extract, cetearyl alcohol, ceteth-20, dimethicone, disodium EDTA, glycerin, glyceryl caprylate, glyceryl stearate, hydroxyacetophenone, isopropyl myristate, mineral oil, phenoxyethanol, sodium stearoyl glutamate, triethanolamine, water
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
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INGREDIENTS AND APPEARANCE
FLEXITOL HAPPY LITTLE BODIES ECZEMA RELIEF
oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43251-4927 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength oatmeal (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) oatmeal 50 mg in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Water (UNII: 059QF0KO0R) Carbomer Interpolymer type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) Calendula Officinalis Flower (UNII: P0M7O4Y7YD) Cetostearyl Alcohol (UNII: 2DMT128M1S) Ceteth-20 (UNII: I835H2IHHX) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Glyceryl Monocaprylate (UNII: TM2TZD4G4A) Glyceryl Monostearate (UNII: 230OU9XXE4) Glycerin (UNII: PDC6A3C0OX) Hydroxyacetophenone (UNII: G1L3HT4CMH) Isopropyl Myristate (UNII: 0RE8K4LNJS) Mineral Oil (UNII: T5L8T28FGP) Phenoxyethanol (UNII: HIE492ZZ3T) Trolamine (UNII: 9O3K93S3TK) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43251-4927-1 1 in 1 CARTON 01/02/2022 1 56 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:43251-4927-2 1 g in 1 PACKET; Type 0: Not a Combination Product 01/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M016 11/29/2021 Labeler - LaCorium Health USA Inc (111254392) Establishment Name Address ID/FEI Business Operations Bentley Laboratories, LLC 068351753 MANUFACTURE(43251-4927)