Extra Strength Body Cream
FDA Label NDC 61328-119

Full FDA labeling including 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

allantoin, aloe barbadensis leaf juice, avena sativa (oat) extract, avena sativa kernel oil, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, caprylyl–caprylate/caprate citric acid, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) extract, moringa oil/hydrogenated moringa oil esters, oryza sativa (rice) bran extract, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, vitis vinifera (grape) seed oil, water/aqua, xanthan gum.

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