Soothe your skin

Manufacturer
PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag
Effective date
2021-08-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:38:00

Label at a glance#

ProductSoothe your skin
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults and children 3 months of age and older: Apply as needed. For children under 3 months of age: Consult a doctor.

Storage and handling

Store in a cool, dry place. Tamper-evident for your protection. Use only if safety seal is intact.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Colloidal Oatmeal 1%...........Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Use only as directed.

Keep away from excessive heat or flame.

OTC - WHEN USING SECTION

When using this product:

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 3 months of age and older: Apply as needed.

For children under 3 months of age: Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store in a cool, dry place.
  • Tamper-evident for your protection. Use only if safety seal is intact.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Glycerin, Tocopheryl (Vitamin E) Acetate, Undecane, Glyceryl Stearate, Panthenol, Triticum Vulgare (Wheat) Germ Oil, Squalane, Pentylene Glycol, Cetearyl Alcohol, Polyglyceryl-6 Palmitate/Succinate, Tridecane, Hydroxyacetophenone, Sodium Lactate, Sodium PCA, Glycine, Fructose, Urea, Niacinamide, Sodium Benzoate, Lactic Acid, Xylitylglucoside, Anhydroxylitol, Xylitol, Tocopherol, Decyl Glucoside

Questions or Comments?

OTC - QUESTIONS SECTION

888-819-6472

Monday-Friday, 9am-5pm CT

Report any serious side effects to number above.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 72683-007-01

Asutra*

Soothe your skin

1% Colloidal Oatmeal

Eczema Cream Skin Protectant

3.4 fl oz. | 100 ml.

11

22

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72683-00772683-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f04b4731-e0e8-5524-e053-2995a90a5efcca3b16f1-abe9-d7c8-e053-2995a90abe522022-12-20WarningsExact identifier
spl set id: ca3b16f1-abe9-d7c8-e053-2995a90abe52

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.