84148-018

84148-018
SPL v1
SPL
SPL Set ID 48652b9c-4063-cc16-e063-6394a90a3b86
Route
CUTANEOUS
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g) Oatmeal (1 g)
Inactive Ingredients
Mineral Oil Beeswax Butyrospermum Parkii (shea) Butter Olea Europaea (olive) Fruit Oil Vitis Vinifera (grape) Seed Oil Aloe Vera Leaf Oil Water Mel Prunus Amygdalus Dulcis (sweet Almond) Oil Helianthus Annuus (sunflower) Seed Oil Avena Sativa (oat) Kernel Oil Magnesium Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

Description

1.0% Colloidal Oatmeal 0.5% Allantoin

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

1.0% Colloidal Oatmeal 0.5% Allantoin

Uses

Temporarily protects and helps relieve minor

skin irritation and itching due to eczema, psoriasis,

rashes, or dry skin.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if condition worsens or symptoms persist > 7 days

Section 50567-7

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

Do not use on deep or puncture wounds, animal bites, serious burns.

Stop use and ask a doctor if condition worsens or

symptoms persist > 7 days. Keep out of reach of

children. If swallowed, get medical help or contact

a Poison Control Center immediately.

Directions



Adults and children 2 yrs and older: apply to

affected area as needed. Children under 2 yrs: ask

a doctor.

Do Not Use

Do not use on deep or puncture wounds,

Other Information

Store at room temperature. Contains honey-not for infants < 12 months.

Active Ingredient(s)

1.0% Colloidal Oatmeal

0.5% Allantoin

Inactive Ingredients

Mineral Oil, Beeswax, Butyrospermum parkii (Shea) Butter, Olea europaea (Olive) Fruit Oil, Vitis vinifera (Grape)

Seed Oil, Aloe barbadensis Leaf Water, Water (Aqua), Mel (Honey), Prunus amygdalus dulcis

(Sweet Almond) Oil, Helianthus annuus (Sunflower) Seed Oil, Avena sativa (Oat) Kernel

Oil, Magnesium Sulfate.

Package Label Principal Display Panel


Structured Label Content

Uses

Temporarily protects and helps relieve minor

skin irritation and itching due to eczema, psoriasis,

rashes, or dry skin.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or symptoms persist > 7 days

Section 50567-7 (50567-7)

If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Skin Protectant

Warnings

Do not use on deep or puncture wounds, animal bites, serious burns.

Stop use and ask a doctor if condition worsens or

symptoms persist > 7 days. Keep out of reach of

children. If swallowed, get medical help or contact

a Poison Control Center immediately.

Directions



Adults and children 2 yrs and older: apply to

affected area as needed. Children under 2 yrs: ask

a doctor.

Do Not Use (Do not use)

Do not use on deep or puncture wounds,

Other Information (Other information)

Store at room temperature. Contains honey-not for infants < 12 months.

Active Ingredient(s)

1.0% Colloidal Oatmeal

0.5% Allantoin

Inactive Ingredients (Inactive ingredients)

Mineral Oil, Beeswax, Butyrospermum parkii (Shea) Butter, Olea europaea (Olive) Fruit Oil, Vitis vinifera (Grape)

Seed Oil, Aloe barbadensis Leaf Water, Water (Aqua), Mel (Honey), Prunus amygdalus dulcis

(Sweet Almond) Oil, Helianthus annuus (Sunflower) Seed Oil, Avena sativa (Oat) Kernel

Oil, Magnesium Sulfate.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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