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NDC 65112-0250-02 EczaCalm 0.008 g/g Details
EczaCalm 0.008 g/g
EczaCalm is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by I Shay Cosmetics Inc. The primary component is OATMEAL.
Product Information
NDC | 65112-0250 |
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Product ID | 65112-250_eb6a1afb-8227-88f6-e053-2995a90a1207 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | EczaCalm |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Skin Protectant |
Product Type | HUMAN OTC DRUG |
Dosage Form | OINTMENT |
Route | TOPICAL |
Active Ingredient Strength | 0.008 |
Active Ingredient Units | g/g |
Substance Name | OATMEAL |
Labeler Name | I Shay Cosmetics Inc |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part347 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 65112-0250-02 (65112025002)
NDC Package Code | 65112-250-02 |
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Billing NDC | 65112025002 |
Package | 1 TUBE in 1 BOX (65112-250-02) / 48.2 g in 1 TUBE (65112-250-01) |
Marketing Start Date | 2019-04-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b9e51c5c-e4c9-ed0b-e053-2995a90ad193 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
ECZACALM
skin protectant ointment |
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Labeler - I Shay Cosmetics Inc (151582384) |
Revised: 10/2022
Document Id: eb6a1afb-8227-88f6-e053-2995a90a1207
Set id: b9e51c5c-e4c9-ed0b-e053-2995a90ad193
Version: 3
Effective Time: 20221019