ECZACALM- skin protectant ointment 
I Shay Cosmetics Inc

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.

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EczaCalm Cream

Organic Colloidal Oatmeal 0.8% ... Skin Protectant

Skin Protectant

WARNING: Keep out of reach of children.

Temporarily protects and helps relieve minor skin irritation and itching due to:

Eczema, rashes, insect bites, poison ivy, oak or sumac

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.

For external use only.

Do not use on:
deep puncture wounds
serious burns
animal bites

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

Apply as needed

drug panel drug panel

ECZACALM 
skin protectant ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65112-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.008 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SAFFLOWER OIL (UNII: 65UEH262IS) 0.67 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65112-250-021 in 1 BOX04/01/2019
1NDC:65112-250-0148.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2019
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
 
I Shay Cosmetics Inc