extra strength body

extra strength body
SPL v7
SPL
SPL Set ID 32ba5f29-c037-44dd-b5b1-59001ac50753
Route
topical
Published
Effective Date 2022-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oatmeal (2 g)
Inactive Ingredients
allantoin aloe vera leaf avena sativa whole oat kernel oil shea butter medium-chain triglycerides caprylyl caprylate/caprate anhydrous citric acid ethylhexylglycerin glycerin glyceryl monostearate sunflower oil helianthus annuus whole moringa oleifera seed oil rice bran phenoxyethanol polyglyceryl-2 stearate potassium sorbate almond oil rosemary jojoba oil stearyl alcohol tocopherol trisodium ethylenediamine disuccinate grape seed oil water xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-01-30

Purpose

Skin protectant

Description

Colloidal Oatmeal 2%


Medication Information

Warnings

For external use only.

When using this product, avoid contact with 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.
Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

Purpose

Skin protectant

Directions

Apply generously to affected areas, especially after bathing.

Inactive Ingredients

Water/Eau/Aqua, Glycerin, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Stearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Caprylyl Caprylate/Caprate, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Oil, Allantoin, Xanthan Gum, Avena Sativa (Oat) Bran Extract, Potassium Sorbate, Citric Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ethylhexylglycerin, Moringa Oil/Hydrogenated Moringa Oil Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Trisodium Ethylenediamine Disuccinate, Aloe Barbadensis Leaf Juice, Tocopherol, Helianthus Annuus (Sunflower) Extract.

Description

Colloidal Oatmeal 2%

Principal Display Panel

Section 50565-1

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

Section 50567-7

When using this product

  • Avoid contact with eyes
Section 50569-3

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
Active Ingredients

Colloidal Oatmeal 2%


Structured Label Content

Warnings

For external use only.

When using this product, avoid contact with 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.
Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

Purpose

Skin protectant

Directions

Apply generously to affected areas, especially after bathing.

Inactive Ingredients

Water/Eau/Aqua, Glycerin, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Stearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Caprylyl Caprylate/Caprate, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Oil, Allantoin, Xanthan Gum, Avena Sativa (Oat) Bran Extract, Potassium Sorbate, Citric Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ethylhexylglycerin, Moringa Oil/Hydrogenated Moringa Oil Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Trisodium Ethylenediamine Disuccinate, Aloe Barbadensis Leaf Juice, Tocopherol, Helianthus Annuus (Sunflower) Extract.

Principal Display Panel

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 50567-7 (50567-7)

When using this product

  • Avoid contact with eyes
Section 50569-3 (50569-3)

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
Active Ingredients

Colloidal Oatmeal 2%


Advanced Ingredient Data


Raw Label Data

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