Satya Organic Fragrance-free Eczema Relief

SPL v7

SPL

SPL Set ID df37848d-afca-45b0-80b3-d24353123d18

Route

TOPICAL

Published

Effective Date 2022-08-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Oatmeal (10 mg)

Inactive Ingredients

Synthetic Beeswax Calendula Officinalis Flower Jojoba Oil Almond Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2022-08-17

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

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

• rashes • eczema • poison ivy, oak or sumac • insect bites

Dosage and Administration

Directions

apply as needed

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product do not get into eyes

Section 51727-6

Inactive ingredients Beeswax*, Calendula Flower Oil*, Jojoba Oil*, Sweet Almond Oil.*

* USDA certified organic ingredient.

Section 51945-4

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 82590-030-02

0.34 oz Balm

Section 53413-1

Questions? 778.655.9006

@SATYAORGANIC

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active ingredient

Colloidal oatmeal 1%

Structured Label Content

Indications and Usage (34067-9)

Uses

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

• rashes • eczema • poison ivy, oak or sumac • insect bites

Dosage and Administration (34068-7)

Directions

apply as needed

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not get into eyes

Section 51727-6 (51727-6)

Inactive ingredients Beeswax*, Calendula Flower Oil*, Jojoba Oil*, Sweet Almond Oil.*

* USDA certified organic ingredient.

Section 51945-4 (51945-4)

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 82590-030-02

0.34 oz Balm

Section 53413-1 (53413-1)

Questions? 778.655.9006

@SATYAORGANIC

Section 55105-1 (55105-1)

Purpose

Skin protectant

Section 55106-9 (55106-9)

Active ingredient

Colloidal oatmeal 1%

Advanced Ingredient Data

[{"name": "OATMEAL", "unii": "8PI54V663Y", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SYNTHETIC BEESWAX", "unii": "08MNR5YE2R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALMOND OIL", "unii": "66YXD4DKO9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema • poison ivy, oak or sumac • insect bites", "34068-7": "Directions apply as needed", "34071-1": "Warnings For external use only.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "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", "50567-7": "When using this product do not get into eyes", "51727-6": "Inactive ingredients Beeswax*, Calendula Flower Oil*, Jojoba Oil*, Sweet Almond Oil.* * USDA certified organic ingredient.", "51945-4": "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 82590-030-02 0.34 oz Balm", "53413-1": "Questions? 778.655.9006 @SATYAORGANIC", "55105-1": "Purpose Skin protectant", "55106-9": "Active ingredient Colloidal oatmeal 1%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:20.800450 · Updated: 2026-03-14T23:01:21.342577