Extra Strength Body Cream
FDA Label NDC 61328-119

10 label sections · Submitted to the FDA by Skinfix, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skinfix, Inc. for the product Extra Strength Body (NDC 61328-119). 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 active ingredients, purpose, uses, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Colloidal Oatmeal 2%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

Warnings

For external use only.

When using this product, avoid contact with eyes.

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 - When Using

When using this product

  • Avoid contact with eyes

Otc - Ask Doctor

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 right away.

Directions

Apply generously to affected areas, especially after bathing.

Inactive Ingredients

Water/Eau/Aqua, Glycerin, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Stearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Caprylyl Caprylate/Caprate, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Oil, Allantoin, Xanthan Gum, Avena Sativa (Oat) Bran Extract, Potassium Sorbate, Citric Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ethylhexylglycerin, Moringa Oil/Hydrogenated Moringa Oil Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Trisodium Ethylenediamine Disuccinate, Aloe Barbadensis Leaf Juice, Tocopherol, Helianthus Annuus (Sunflower) Extract.

Principal Display Panel

61328-119-28 (61328 119 28v2 R2)

61328-119-28 (61328 119 28v2 R2)

* Please review the disclaimer below.