SPL v2
SPL
SPL Set ID 8d4b4a14-b631-f2fa-e053-2a95a90a932f
Route
TOPICAL
Published
Effective Date 2019-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (0.5 g)
Inactive Ingredients
Coconut Water Bee Pollen Honeydew Melon Safflower Oil Dehydroacetic Acid Bergamot Oil Xanthan Gum Coconut Oil Cetearyl Olivate Sorbitan Olivate Cetostearyl Alcohol Glycerin Macadamia Oil Shea Butter Alpha-tocopherol Acetate Benzyl Alcohol Anhydrous Citric Acid Sodium Stearoyl Glutamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-15

Description

Colloidal Oatmeal 0.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema • insect bites

Dosage and Administration

Apply twice daily for best results.

Description

Colloidal Oatmeal 0.5%

Section 44425-7

• Safe for the face and body.

• External use only. If irritation should occur discontinue use.

• When using this product you may notice a slight tingling sensation; this is normal and will subside.

• Do not use if quality seal is broken or missing.

Section 50565-1

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

Section 50566-9

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.

Section 50567-7

When using this product

• do not get into eyes.

Section 51727-6

Myriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.

Section 51945-4

ATOPIS

Eczema

Therapy Cream

Skin Protectant



Cream for eczema, rash and insect bite relief

Clinically shown to relieve and protect dry, itchy, irritated skin, due to eczema



• Soothes, nourishes and restores moisture

• No parabens, no solvents, no artificial fragrances

• Clinically trialed on humans, not tested on animals

Product of New Zealand

E Net Wt 2.6 oz/75g

Section 53413-1

(855) 969-5002 or [email protected]

Section 55105-1

Colloidal Oatmeal 0.5%...... Skin Protectant

Section 55106-9

Colloidal Oatmeal 0.5%


Structured Label Content

Indications and Usage (34067-9)

temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema • insect bites

Dosage and Administration (34068-7)

Apply twice daily for best results.

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

• Safe for the face and body.

• External use only. If irritation should occur discontinue use.

• When using this product you may notice a slight tingling sensation; this is normal and will subside.

• Do not use if quality seal is broken or missing.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

• do not get into eyes.

Section 51727-6 (51727-6)

Myriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.

Section 51945-4 (51945-4)

ATOPIS

Eczema

Therapy Cream

Skin Protectant



Cream for eczema, rash and insect bite relief

Clinically shown to relieve and protect dry, itchy, irritated skin, due to eczema



• Soothes, nourishes and restores moisture

• No parabens, no solvents, no artificial fragrances

• Clinically trialed on humans, not tested on animals

Product of New Zealand

E Net Wt 2.6 oz/75g

Section 53413-1 (53413-1)

(855) 969-5002 or [email protected]

Section 55105-1 (55105-1)

Colloidal Oatmeal 0.5%...... Skin Protectant

Section 55106-9 (55106-9)

Colloidal Oatmeal 0.5%


Advanced Ingredient Data


Raw Label Data

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