ECZACALM- skin protectant ointment

EczaCalm by

Drug Labeling and Warnings

EczaCalm by is a Otc medication manufactured, distributed, or labeled by I Shay Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Organic Colloidal Oatmeal 0.8% ... Skin Protectant

PURPOSE

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

WARNING: Keep out of reach of children.

INDICATIONS & USAGE

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

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

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

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

DOSAGE & ADMINISTRATION

Apply as needed

PRINCIPAL DISPLAY PANEL

drug panel

INGREDIENTS AND APPEARANCE

ECZACALM 
skin protectant ointment

Product 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)