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

Purpose

Skin Protectant

Description

1.0% Colloidal Oatmeal 0.5% Allantoin


Medication Information

Warnings

For external use only.

Purpose

Skin Protectant

Directions

• apply to affected area as needed

• suitable for daily use

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

Other Information

• store at room temperature

• avoid excessive heat

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.

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

Do Not Use

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

Active Ingredient(s)

1.0% Colloidal Oatmeal

0.5% Allantoin

Package Label Principal Display Panel


Structured Label Content

Warnings

For external use only.

Purpose

Skin Protectant

Directions

• apply to affected area as needed

• suitable for daily use

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

Other Information (Other information)

• store at room temperature

• avoid excessive heat

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.

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

Do Not Use (Do not use)

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

Active Ingredient(s)

1.0% Colloidal Oatmeal

0.5% Allantoin

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


Advanced Ingredient Data


Raw Label Data

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