Eczema Lotion/shampoo
FDA Label NDC 52915-010

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 52915-010). 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, otc - when using, otc - stop use, 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.

Otc - When Using

When using this product

  • patch test before use
  • keep out of eyes
  • clean with soap and water to remove
  • to avoid slipping, use mat in tub or shower

Otc - Stop Use

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

  • dispense a dime-to-quarter sized amount into palm, massage into wet hair starting at the scalp and working to the ends. Rinse.
  • for extra cleansing, allow to sit for 30 seconds and then rinse.

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, decyl glucoside, lauryl glucoside, quillaja saponaria bark extract, glycerine, allantoin, calendula officinalis flower extract, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil, hydrolyzed quinoa, xanthan gum, panthenol, phytic acid, gluconolactone, sodium benzoate.

Principal Display Panel - 562 Ml Bottle Label

CALIF♥RNIA BABY®
safe ♥ natural ♥ fun

NEW &
IMPROVED!

therapeutic relief

COLLOIDAL OATMEAL (CONTAINS GLUTEN)

ECZEMA
SHAMPOO & BODYWASH

SKIN PROTECTANT • GENTLY CLEANSES SENSITIVE OR IRRITATED SKIN
DUE TO ECZEMA • HELPS HEAL & PROTECT DELICATE SKIN
NO SULFATES, STEROIDS OR ALCOHOL

NO ADDED FRAGRANCE
HAIR, FACE & BODY

ALLERGY
TESTED

• for babies • kids •
• sensitive adults •

562 mL / 19 Fl. Oz.

Principal Display Panel (562 mL Bottle Label)

Principal Display Panel (562 mL Bottle Label)

* Please review the disclaimer below.