Label: ECZEMA RELIEF- colloidal oatmeal ointment
- NDC Code(s): 55910-653-34
- Packager: OLD EAST MAIN CO
- 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 March 7, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Do not use on
- Keep out of reach of children
- Directions
- other information
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Inactive ingredients
water, glycerin, Ricinus communis (castor) seed oil, mineral oil, cetyl alcohol, glyceryl stearate, caprylic/capric triglyceride, octyldodecanol, cetyl palmitate, PEG-40 stearate, Glycyrrhiza glabra (licorice) root extract, ceramide NP, 1,2-hexanediol, phenoxyethanol, piroctone olamine, caprylyl glycol, ethylhexylglycerin, benzyl alcohol, citric acid
- Adverse reactions
- principal display panel
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INGREDIENTS AND APPEARANCE
ECZEMA RELIEF
colloidal oatmeal ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-653 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 10 mg in 11 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) CASTOR OIL (UNII: D5340Y2I9G) mineral oil (UNII: T5L8T28FGP) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) octyldodecanol (UNII: 461N1O614Y) CETYL PALMITATE (UNII: 5ZA2S6B08X) PEG-40 stearate (UNII: ECU18C66Q7) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) ceramide NP (UNII: 4370DF050B) 1,2-hexanediol (UNII: TR046Y3K1G) phenoxyethanol (UNII: HIE492ZZ3T) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) caprylyl glycol (UNII: 00YIU5438U) ethylhexylglycerin (UNII: 147D247K3P) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRIC ACID ACETATE (UNII: DSO12WL7AU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-653-34 226 g in 1 TUBE; Type 0: Not a Combination Product 12/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/07/2021 Labeler - OLD EAST MAIN CO (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-653) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-653)