Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 91163267-c2aa-47b3-b290-d1605536d806
Route
TOPICAL
Published
Effective Date 2021-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (0.01 g)
Inactive Ingredients
Ascorbyl Palmitate Behenic Acid Shea Butter C12-16 Alcohols Calcium Gluconate N-hexanoylsphingosine Medium-chain Triglycerides Caprylyl Glycol Ceramide Ap Ceramide 1 Ceramide Eos Ceramide Np Ceramide Ng Ceteareth-25 Cetyl Alcohol Cholesterol Curcuma Kwangsiensis Root Cynara Scolymus Leaf Decyl Glucoside Dimethicone Glycyrrhizinate Dipotassium Edetate Disodium Anhydrous Ethylhexylglycerin Gluconolactone Glycerin Sunflower Oil Hexylene Glycol Hydrogenated Soybean Lecithin Lecithin, Soybean Maltodextrin Ophiopogon Japonicus Root Prickly Pear Fruit Palmitic Acid Panthenol Phenoxyethanol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Potassium Sorbate Propanediol Sodium Benzoate Tocopherol Water Xanthan Gum Yeast, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-09

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 due to • rashes • eczema.

Warnings

For external use only.

Directions

Apply an even layer over face and neck as needed. Avoid eye area. Use AM + PM after Sensitive Skin Treatment.

Questions?

1-888-995-5656

Active Ingredient

Colloidal

Oatmeal 1 %

Inactive Ingredients

Aqua/Eau/Water, Ascorbyl Palmitate, Behenic Acid, Butyrospermum Parkii (Shea) Butter, C12-16 Alcohols, Calcium Gluconate, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Curcuma Wenyujin/Curcuma Kwangsiensis Rhizome Extract, Cynara Scolymus (Artichoke) Leaf Extract, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Hydrogenated Lecithin, Lecithin, Maltodextrin, Ophiopogon Japonicus Root Extract, Opuntia Ficus-lndica Fruit Extract, Palmitic Acid, Panthenol, Phenoxyethanol, Polysilicone-11, Potassium Sorbate, Propanediol, Sodium Acrylates Copolymer, Sodium Benzoate, Tocopherol, Xanthan Gum, Yeast Extract.

When Using This Product
  • do not get into 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.
Keep Out of Reach of Children.

If product is swallowed, get medical help right away.

Principal Display Panel 50 Ml Tube Label

RODAN+FIELDS

SOOTHE

Moisturizing Rescue Cream

3

Colloidal Oatmeal

Skin Protectant

Principal Display Panel 50 Ml Carton Label

RODAN+FIELDS

SOOTHE

Moisturizing Rescue Cream

3

50 mL/ 1.7 Fl. Oz. U.S.

Colloidal Oatmeal Cream


Structured Label Content

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema.

Purpose

Skin Protectant

Warnings

For external use only.

Directions

Apply an even layer over face and neck as needed. Avoid eye area. Use AM + PM after Sensitive Skin Treatment.

Questions?

1-888-995-5656

Active Ingredient

Colloidal

Oatmeal 1 %

Inactive Ingredients

Aqua/Eau/Water, Ascorbyl Palmitate, Behenic Acid, Butyrospermum Parkii (Shea) Butter, C12-16 Alcohols, Calcium Gluconate, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Curcuma Wenyujin/Curcuma Kwangsiensis Rhizome Extract, Cynara Scolymus (Artichoke) Leaf Extract, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Hydrogenated Lecithin, Lecithin, Maltodextrin, Ophiopogon Japonicus Root Extract, Opuntia Ficus-lndica Fruit Extract, Palmitic Acid, Panthenol, Phenoxyethanol, Polysilicone-11, Potassium Sorbate, Propanediol, Sodium Acrylates Copolymer, Sodium Benzoate, Tocopherol, Xanthan Gum, Yeast Extract.

When Using This Product (When using this product)
  • do not get into eyes.
Stop Use and Ask A Doctor If (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.
Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help right away.

Principal Display Panel 50 Ml Tube Label (Principal Display Panel - 50 mL Tube Label)

RODAN+FIELDS

SOOTHE

Moisturizing Rescue Cream

3

Colloidal Oatmeal

Skin Protectant

Principal Display Panel 50 Ml Carton Label (Principal Display Panel - 50 mL Carton Label)

RODAN+FIELDS

SOOTHE

Moisturizing Rescue Cream

3

50 mL/ 1.7 Fl. Oz. U.S.

Colloidal Oatmeal Cream


Advanced Ingredient Data


Raw Label Data

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