Serawise Eczema Rescue Cream

Serawise Eczema Rescue Cream
SPL v1
SPL
SPL Set ID e805866a-2349-4b86-bc83-a7c859cb9403
Route
TOPICAL
Published
Effective Date 2024-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 mg)
Inactive Ingredients
Beeswax Shea Butter Calcium Gluconate Ceteareth-20 Cetearyl Alcohol Cyanocobalamin Dimethicone Gluconolactone Glycerin Glyceryl Stearate Hypericum Perforatum Leaf Peg-100 Stearate Persea Gratissima (avocado) Oil Sodium Benzoate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-02

Description

Colloidal oatmeal 1%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Colloidal oatmeal 1%

Uses

temporarily protects and helps relieve minor skin irritation and itching duee to:

  • rashes
  • eczema
  • poison ivy, oak, or sumac 
  • insect bites
Warnings

For external use only

Directions

Apply as Needed

Active Ingredient

Colloidal oatmeal 1%

Other Information

Keep away from excessive heat and direct sun.

Package Labeling:

Inactive Ingredients

Beeswax, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Ceteareth-20, Cetearyl Alcohol, Cyanocobalamin (VitB12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).

When Using This Product
  • do not get into eyes.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center right away.

Stop Use and Consult A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses

temporarily protects and helps relieve minor skin irritation and itching duee to:

  • rashes
  • eczema
  • poison ivy, oak, or sumac 
  • insect bites
Purpose

Skin protectant

Warnings

For external use only

Directions

Apply as Needed

Active Ingredient (Active ingredient)

Colloidal oatmeal 1%

Other Information

Keep away from excessive heat and direct sun.

Package Labeling:

Inactive Ingredients

Beeswax, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Ceteareth-20, Cetearyl Alcohol, Cyanocobalamin (VitB12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).

When Using This Product (When using this product)
  • do not get into eyes.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a poison control center right away.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data


Raw Label Data

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