Extra Strength Body Cream

Extra Strength Body Cream
SPL v2
SPL
SPL Set ID 80b52587-927b-f869-e053-2a91aa0a21a1
Route
TOPICAL
Published
Effective Date 2019-01-14
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 2015-05-23

Description

Colloidal Oatmeal 2%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Colloidal Oatmeal 2%

Uses

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

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
Section 51945-4

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.
Directions

Apply generously to affected areas, especially after bathing.

Active Ingredients

Colloidal Oatmeal 2%

Inactive Ingredients

allantoin, aloe barbadensis leaf juice, avena sativa (oat) extract, avena sativa kernel oil, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, caprylyl–caprylate/caprate citric acid, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) extract, moringa oil/hydrogenated moringa oil esters, oryza sativa (rice) bran extract, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, vitis vinifera (grape) seed oil, water/aqua, xanthan gum.


Structured Label Content

Uses

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

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
Section 51945-4 (51945-4)

Purpose

Skin protectant

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.
Directions

Apply generously to affected areas, especially after bathing.

Active Ingredients

Colloidal Oatmeal 2%

Inactive Ingredients

allantoin, aloe barbadensis leaf juice, avena sativa (oat) extract, avena sativa kernel oil, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, caprylyl–caprylate/caprate citric acid, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) extract, moringa oil/hydrogenated moringa oil esters, oryza sativa (rice) bran extract, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, vitis vinifera (grape) seed oil, water/aqua, xanthan gum.


Advanced Ingredient Data


Raw Label Data

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