Derma Breeze Skin Protectant Cream
FDA Label NDC 69475-5411

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greyson International, Inc. for the product Derma Breeze Skin Protectant Cream (NDC 69475-5411). 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

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

Warnings

For external use only

Otc - When Using

When using this product

do not get into eyes

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 a Poison Control Center immediately

Directions

apply as needed

Inactive Ingredients

Water, Medium-Chain Triglycerides, Distearyldimonium Chloride, Saccharide Isomerate, Cetostearyl alcohol, Isocetyl Stearate, Curdlan, Lactic Acid,Glyceryl Monostearate, PPG-51/SMDI Copolymer, Phenoxyethanol, Cetyl Alcohol, Propylene Glycol Stearate, Sodium Chloride, Alpha-Tocopherol Acetate, PEG-10 Soy Sterol