SATYA ORGANIC FRAGRANCE-FREE ECZEMA RELIEF- colloidal oatmeal ointment

Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF by

Drug Labeling and Warnings

Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF by is a Otc medication manufactured, distributed, or labeled by Satya Organic Inc., Vegewax Candleworx Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Colloidal oatmeal 1%

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses

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

rashes  eczema  poison ivy, oak or sumac  insect bites

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product do not get into eyes

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

apply as needed

INACTIVE INGREDIENT

InactiveingredientsBeeswax*, Calendula Flower Oil*, Jojoba Oil*, Sweet Almond Oil.*

* USDA certified organic ingredient.

SPL UNCLASSIFIED SECTION

Questions? 778.655.9006

@SATYAORGANIC

PRINCIPAL DISPLAY PANEL

Satya

ORGANIC

FRAGRANCE-FREE

ECZEMA

RELIEF

Skin Protectant Balm

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

eczema ♦ rashes ♦ insect bites ♦ poison ivy, oat or sumac

Colloidal Oatmeal 1%

USDA Certified Organic    NDC 82590-030-01

NET CONTETNS 1 FL OZ (30 ML) BALM

INGREDIENTS AND APPEARANCE

SATYA ORGANIC FRAGRANCE-FREE ECZEMA RELIEF 
colloidal oatmeal ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82590-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
JOJOBA OIL (UNII: 724GKU717M)
ALMOND OIL (UNII: 66YXD4DKO9)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82590-030-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2022

Labeler - Satya Organic Inc. (203272521)

Registrant - Satya Organic Inc. (203272521)

Establishment
Name	Address	ID/FEI	Business Operations
Vegewax Candleworx Ltd		201050882	manufacture(82590-030)