Terranea Cares Wellness Kit
FDA Label NDC 69491-304

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Buzz Export Services Pty., Ltd. for the product Terranea Cares Wellness Kit (NDC 69491-304). 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 ingredient, purpose, uses, warnings, when using this product, stop using and ask a doctor if, 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 Ingredient

Ethyl Alcohol 75% (v/v)

Ethyl Alcohol 75% (v/v)

Purpose

Antiseptic

Antiseptic

Uses

To help reduce bacteria on the skin.

  • To help reduce bacteria on the skin.

Warnings

  • For external use only.
  • Flammable. Keep away from fire or flame.
    • For external use only.
    • Do not dispose of wipes in flush toilets.

      • Flammable

      • Keep away from fire or flame.

When Using This Product

  • avoid contact with eyes.
  • if contact occurs, rinse thoroughly with water.
    • avoid contact with eyes.
    • if contact occurs, rinse thoroughly with water.

Stop Using And Ask A Doctor If

irritation or redness develops and lasts.

  • irritation or redness develops and lasts.

Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact a poison control center immediately.

  • In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

  • Squeeze a significant amount in your palm and rub hands until full dry. No rinsing required.

    • Apply to hands or surfaces.
    No rinsing required.
    Discard after use.

Other Information

  • Store below 110°f (43°C).
    • Store below 110°F (43°C).
    • May discolor certain fabrics or surfaces.

Inactive Ingredients

Water (Aqua), Glycerin, Acrylates/C-10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aminomethyl Propanol.

Aqua (Water), Glycerin. Polyquaternium-37, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

Kit Label:

Kit (Kit)

Kit (Kit)

Package Labeling:69491-301-00

Label. (Label.)

Label. (Label.)

Package Labeling:69491-303-00

Label2 (Label2)

Label2 (Label2)

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