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

Purpose

Skin protectant

Description

Colloidal oatmeal 1%


Medication Information

Warnings

For external use only

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)
Active Ingredients

Colloidal oatmeal 1%


Structured Label Content

Warnings

For external use only

Indications and Usage (34067-9)

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

  • rashes
  • eczema
Purpose

Skin protectant

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)
Active Ingredients

Colloidal oatmeal 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)