Renew Targeted Eczema Treatment

Renew Targeted Eczema Treatment
SPL v3
SPL
SPL Set ID 198c7caf-576b-1466-e063-6394a90afe25
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (0.5 g)
Inactive Ingredients
Petrolatum Isopropyl Palmitate Allantoin Distearyldimonium Chloride Glycerin Cetyl Alcohol Water Benzyl Alcohol Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Colloidal oatmeal 1%

Purpose

Skin protectant


Medication Information

Indications and Usage

Uses Temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • eczema
Purpose

Skin protectant

Dosage and Administration

Directions

  • apply as needed or as directed by a doctor
  • for children under 2 years of age: ask a doctor
Description

Colloidal oatmeal 1%

Section 50565-1

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

Section 50566-9

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 50567-7

When using this product avoid contact with eyes

Section 51727-6

water, glycerin, petrolatum, distearyldimonium chloride, isopropyl palmitate, cetyl alcohol, allantoin, benzyl alcohol, citric acid

Section 51945-4

Section 60561-8

Other information

  • for mild to moderate eczema
  • store below 86 F (30 C)
Warnings

For external use only

Active Ingredients

Colloidal oatmeal 1%


Structured Label Content

Indications and Usage (34067-9)

Uses Temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes
  • eczema
Dosage and Administration (34068-7)

Directions

  • apply as needed or as directed by a doctor
  • for children under 2 years of age: ask a doctor
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 50566-9 (50566-9)

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 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 51727-6 (51727-6)

water, glycerin, petrolatum, distearyldimonium chloride, isopropyl palmitate, cetyl alcohol, allantoin, benzyl alcohol, citric acid

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

Other information

  • for mild to moderate eczema
  • store below 86 F (30 C)
Purpose

Skin protectant

Warnings

For external use only

Active Ingredients

Colloidal oatmeal 1%


Advanced Ingredient Data


Raw Label Data

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