Eczema Cream
FDA Label NDC 52915-120

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Organic & Sustainable Beauty for the product Eczema (NDC 52915-120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

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

  • rashes
  • eczema
  • poison ivy, oak, or sumac
  • insect bites

Warnings

External use only.

When Using This Product

  • patch test before use
  • keep out of eyes
  • clean with soap and water to remove

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control within the U.S. (1-800-222-1222)

Directions

  • apply liberally onto desired area
  • reapply as needed.

    • Children under 6 months: ask a doctor. Use in combination with our Eczema Shampoo & Bodywash.

Other Information

You may report a serious adverse reaction event from using this product to: 5933 Bowcroft St. Los Angeles, CA 90016

Inactive Ingredients

Water, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate and sorbitan olivate, canola oil, allantoin, calendula officinalis flower extract, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, pure essential oils of lavandula angustifolia oil and salvia sclarea oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate.

Principal Display Panel - 133 Ml Container Label

CALIF♥RNIA BABY®
trusted since 1995

NEW &
IMPROVED!

therapeutic relief
COLLOIDAL OATMEAL (CONTAINS GLUTEN)

ECZEMA
CREAM

SKIN PROTECTANT • RELIEVES SKIN DUE TO ECZEMA
OR RASHES • HELPS HEAL & PROTECT DELICATE SKIN
ULTRA MOISTURIZING • STEROID-FREE

CALENDULA & LAVENDER
FACE & BODY

ALLERGY
TESTED

• for babies • kids •
• sensitive adults •

133 mL / 4.5 Fl. Oz.

Principal Display Panel (133 mL Container Label)

Principal Display Panel (133 mL Container Label)

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