Label: EARTHS CARE ECZEMA- oatmeal lotion
- NDC Code(s): 24286-1571-1, 24286-1571-2, 24286-1571-8
- Packager: DLC Laboratories, Inc.
- 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 November 3, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Inactive ingredients
Aloe barbadensis (aloe vera) extract, alpha-bisabolol, Argania spinosa (argan) kernel oil, benzyl alcohol, Butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cetyl hydroxyethylcellulose, citric acid, ethylhexylglycerin, glycerin, heptyl undecylenate, Persea gratissima (avocado) oil, phenoxyethanol, polyglyceryl-3 dicitrate/stearate, potassium sorbate, Prunus amygdalus dulcis (sweet almond) oil, purified water, Simmondsia chinensis (jojoba) oil, tetrasodium EDTA, tocopherols, Zingiber officinale (ginger) root extract.
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- PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
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INGREDIENTS AND APPEARANCE
EARTHS CARE ECZEMA
oatmeal lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1571 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.8 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GINGER OIL (UNII: SAS9Z1SVUK) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) EDETATE SODIUM (UNII: MP1J8420LU) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) ALMOND OIL (UNII: 66YXD4DKO9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) JOJOBA OIL (UNII: 724GKU717M) AVOCADO OIL (UNII: 6VNO72PFC1) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) ARGAN OIL (UNII: 4V59G5UW9X) TOCOPHEROL (UNII: R0ZB2556P8) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BENZYL ALCOHOL (UNII: LKG8494WBH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color white (Off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24286-1571-8 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/19/2018 2 NDC:24286-1571-1 2.9 mL in 1 POUCH; Type 0: Not a Combination Product 08/02/2019 3 NDC:24286-1571-2 12.4 mL in 1 JAR; Type 0: Not a Combination Product 02/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/19/2018 Labeler - DLC Laboratories, Inc. (093351930) Establishment Name Address ID/FEI Business Operations DLC Laboratories, Inc. 093351930 manufacture(24286-1571) , label(24286-1571)