Label: ECZACALM- skin protectant ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 65112-250-01, 65112-250-02 - Packager: I Shay Cosmetics 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 October 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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INACTIVE INGREDIENT
Organic Safflower Oil, Organic Beeswax, Organic Rosehip Seed Oil, Organic Flax Oil, Vitamin E From Sunflowers, Organic Horsetail, Organic Comfrey, Organic Horsetail, Organic Aloe, Organic Calendula, Organic Burdock, Organic Licorice Root, Organic Chamomile, Organic St. John’s Wort, Organic Plantain.
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ECZACALM
skin protectant ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65112-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.008 g in 1 g Inactive Ingredients Ingredient Name Strength SAFFLOWER OIL (UNII: 65UEH262IS) 0.67 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65112-250-02 1 in 1 BOX 04/01/2019 1 NDC:65112-250-01 48.2 g 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 04/01/2019 Labeler - I Shay Cosmetics Inc (151582384)
