ECZACALM- skin protectant ointment

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

INGREDIENTS AND APPEARANCE

ECZACALM
skin protectant ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.008 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
SAFFLOWER OIL (UNII: 65UEH262IS)	0.8 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/01/2019

Labeler - I. Shay Cosmetics (151582384)

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