Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0a710be0-562e-8368-e063-6294a90a3b1b
Route
TOPICAL
Published
Effective Date 2023-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1 g)
Inactive Ingredients
Glycerin Cetearyl Olivate Sheanut Oil Stearic Acid Sunflower Oil Avocado Oil Hyaluronate Sodium Phenoxyethanol Caprylyl Glycol Hexylene Glycol Chamaemelum Nobile Flower Calendula Officinalis Flower Water Sorbitan Olivate Cetostearyl Alcohol Honey Xanthan Gum .alpha.-tocopherol Acetate Citric Acid Monohydrate Ethylhexylglycerin Glyceryl Monostearate Aloe Vera Leaf Cocoa Butter Medium-chain Triglycerides Phytate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-18

Description

Active ingredient Colloidal Oatmeal 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Use Temporarily protects and helps relieve minor skin irritation and itching due to rashes and eczema

Dosage and Administration

Directions Apply as needed.

Description

Active ingredient Colloidal Oatmeal 1%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if • condition worsens • symptoms lasts 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 50570-1

Do not use if condition worsens.

Section 51727-6

Inactive ingredients

water (aqua), glycerin, glyceryl stearate, cetearyl olivate, aloe barbadensis leaf juice, soritan olivate, cetearyl alcohol, theobroma cacao seed butter, butyrospermum parkii nut extract, caprylic/capric triglyceride, sodium phytate, honey, xanthan gum, stearic acid, tocopheryl acetate, helianthus annus (sunflower) seed oil, persea gratissima (avocado) oil, anthemis nobilis flower extract, calendula officinalis flower extract, sodium hyaluronate, citric acid, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, hexylene glycol

Section 51945-4

Section 55105-1

Purpose - Skin Protectant

Section 55106-9

Active ingredient

Colloidal Oatmeal 1%

Section 60561-8

Other information Store below 30°C


Structured Label Content

Indications and Usage (34067-9)

Use Temporarily protects and helps relieve minor skin irritation and itching due to rashes and eczema

Dosage and Administration (34068-7)

Directions Apply as needed.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if • condition worsens • symptoms lasts 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 50570-1 (50570-1)

Do not use if condition worsens.

Section 51727-6 (51727-6)

Inactive ingredients

water (aqua), glycerin, glyceryl stearate, cetearyl olivate, aloe barbadensis leaf juice, soritan olivate, cetearyl alcohol, theobroma cacao seed butter, butyrospermum parkii nut extract, caprylic/capric triglyceride, sodium phytate, honey, xanthan gum, stearic acid, tocopheryl acetate, helianthus annus (sunflower) seed oil, persea gratissima (avocado) oil, anthemis nobilis flower extract, calendula officinalis flower extract, sodium hyaluronate, citric acid, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, hexylene glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose - Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

Colloidal Oatmeal 1%

Section 60561-8 (60561-8)

Other information Store below 30°C


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)