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

Purpose

Skin protectant

Description

Colloidal oatmeal 1%


Medication Information

Warnings

For external use only

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

Directions

Apply as Needed

Other Information

Keep away from excessive heat and direct sun.

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).

Description

Colloidal oatmeal 1%

Active Ingredient

Colloidal oatmeal 1%

Package Labeling:

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

Warnings

For external use only

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

Directions

Apply as Needed

Other Information

Keep away from excessive heat and direct sun.

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).

Active Ingredient (Active ingredient)

Colloidal oatmeal 1%

Package Labeling:

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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