SPL v1
SPL
SPL Set ID 30c943aa-d9dc-5c16-e063-6294a90a3c58
Route
TOPICAL
Published
Effective Date 2025-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (1 g)
Inactive Ingredients
Xanthan Gum Arachidyl Alcohol Butylene Glycol Arachidyl Glucoside Tocopherol Tetrasodium Glutamate Diacetate Behenyl Alcohol Propanediol Caprylyl Glycol Isostearyl Isostearate Stearyl Alcohol Citric Acid Caprylhydroxamic Acid Cetearyl Alcohol Caprylic/capric Triglyceride Simmondsia Chinensis (jojoba) Seed Oil Vincetoxicum Atratum Whole Hydroxyacetophenone Algin Sophora Flavescens Root Sodium Hydroxide Water Glycerin Butyrospermum Parkii (shea) Butter Nannochloropsis Oculata Methylheptylglycerin Hydrogenated Soybean Lecithin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Warnings For external use only. When using this product, do not get into eyes. 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 the reach of children. If swallowed, get medical advice or contact a Poison Control Center right away.


Medication Information

Warnings and Precautions

Warnings

For external use only. When using this product, do not get into eyes.

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 the reach of children.

If swallowed, get medical advice or contact a Poison Control Center right away.

Indications and Usage

Dosage and Administration

Description

Warnings For external use only. When using this product, do not get into eyes. 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 the reach of children. If swallowed, get medical advice or contact a Poison Control Center right away.

Section 50565-1

Keep out of the reach of children.

If swallowed, get medical advice or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients Water (Aqua), Glycerin, Butyrospermum Parkii (Shea Butter, Cetearyl Alcohol, Isostearyl Isostearate, Propanediol, Stearyl Alcohol.

Caprylic/Capric Triglyceride, Arachidyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Butylene Glycol, Arachidyl Glucoside, Cynanchum Atratum Extract, Methylheptyglycerin, Sophora Angustifolia Root Extract, Hydroxyacetophenone, Tocopherol, Algin, Caprylhydroxamic Acid, Tetrasodium Glutamate Diacetate, Behenyl Alcohol, Xanthan Gum, Caprylyl Glycol, Nannochloropsis Oculata (Algae) Extract, Citric Acid, Sodium Hydroxide, Hydrogenated Lecithin, 1,2-Hexanediol, Sclerotium

Gum, Arnica Montana Flower Extract

Section 51945-4

Section 55105-1

Section 55106-9


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Warnings

For external use only. When using this product, do not get into eyes.

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 the reach of children.

If swallowed, get medical advice or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of the reach of children.

If swallowed, get medical advice or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients Water (Aqua), Glycerin, Butyrospermum Parkii (Shea Butter, Cetearyl Alcohol, Isostearyl Isostearate, Propanediol, Stearyl Alcohol.

Caprylic/Capric Triglyceride, Arachidyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Butylene Glycol, Arachidyl Glucoside, Cynanchum Atratum Extract, Methylheptyglycerin, Sophora Angustifolia Root Extract, Hydroxyacetophenone, Tocopherol, Algin, Caprylhydroxamic Acid, Tetrasodium Glutamate Diacetate, Behenyl Alcohol, Xanthan Gum, Caprylyl Glycol, Nannochloropsis Oculata (Algae) Extract, Citric Acid, Sodium Hydroxide, Hydrogenated Lecithin, 1,2-Hexanediol, Sclerotium

Gum, Arnica Montana Flower Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)