84148-019

84148-019
SPL v1
SPL
SPL Set ID 4865c697-05fc-eac8-e063-6294a90ae541
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
Arginine Peg-100 Stearate Caprylic/capric Triglyceride Water Aloe Vera Leaf Oil Glycerin Cetearyl Alcohol Butyrospermum Parkii (shea) Butter Ethylhexyl Palmitate Squalane Trehalose Cetearyl Olivate Sorbitan Olivate Persea Gratissima (avocado) Oil Mel 1,2-hexanediol Hydroxyacetophenone Glyceryl Stearate Carbomer Sodium Hyaluronate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%)

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

Use

• temporarily protects and helps relieve

minor skin irritation and itching due to

eczema, psoriasis, rashes, or dry skin.

• helps restore and maintain the skin’s

natural moisture barrier.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 50567-7

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

Warnings

For external use only.

Directions

• apply to affected area as needed

• suitable for daily use

• for best results, apply after bathing while skin is still damp

Do Not Use

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

Other Information

• store at room temperature

• avoid excessive heat

Active Ingredient(s)

1.0% Colloidal Oatmeal

0.5% Allantoin

Inactive Ingredients

Water(Aqua), Aloe Barbadensis Leaf Water, Caprylic/Capric Triglyceride,

Glycerin, Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter),

Ethylhexyl Palmitate, Squalane, Trehalose, Cetearyl Olivate, Sorbitan

Olivate, Persea Gratissima (Avocado) Oil, Mel (Honey), 1,2-Hexanediol,

Hydroxyacetophenone, Glyceryl Stearate, PEG-100 Stearate, Carbomer, Arginine,

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,

Sodium Hyaluronate.

Package Label Principal Display Panel


Structured Label Content

Use

• temporarily protects and helps relieve

minor skin irritation and itching due to

eczema, psoriasis, rashes, or dry skin.

• helps restore and maintain the skin’s

natural moisture barrier.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Purpose

Skin Protectant

Warnings

For external use only.

Directions

• apply to affected area as needed

• suitable for daily use

• for best results, apply after bathing while skin is still damp

Do Not Use (Do not use)

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

Other Information (Other information)

• store at room temperature

• avoid excessive heat

Active Ingredient(s)

1.0% Colloidal Oatmeal

0.5% Allantoin

Inactive Ingredients (Inactive ingredients)

Water(Aqua), Aloe Barbadensis Leaf Water, Caprylic/Capric Triglyceride,

Glycerin, Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter),

Ethylhexyl Palmitate, Squalane, Trehalose, Cetearyl Olivate, Sorbitan

Olivate, Persea Gratissima (Avocado) Oil, Mel (Honey), 1,2-Hexanediol,

Hydroxyacetophenone, Glyceryl Stearate, PEG-100 Stearate, Carbomer, Arginine,

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,

Sodium Hyaluronate.

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


Advanced Ingredient Data


Raw Label Data

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