Trauma Plus Gel
FDA Label NDC 44911-0446

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Trauma Plus Gel (NDC 44911-0446). 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:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Calendula Officinalis 1X, Arnica Montana 1X, 30C, Hypericum Perforatum 1X, 30C, Symphytum Officinale 6X, Bellis Perennis 12X, Ledum Palustre 12X, Sulphuricum Acidum 12X, Calcarea Fluorica 30X, Ferrum Phosphoricum 30X, Rhus Tox 30X, Ruta Graveolens 30X, Natrum Sulphuricum 30C.

Indications:

For temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

For temporary relief of pain associated with bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all minor injuries.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

For external use only. If an adverse reaction occurs, discontinue use.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place. Do not expose product to extreme temperatures.

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 small amount every 10 minutes for 3 doses immediately after injury, then 2 to 3 times daily. For topical use only.

Inactive Ingredients:

Purified Water, Whey Protein Concentrate (milk), Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Sodium Hydroxide (Solution), Edetate Disodium (EDTA).

Questions:

Dist. by Energique, Inc., 201 Apple Blvd.
Woodbine, IA 51579   800.869.8078

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TRAUMA+GEL

Net wt. 2 oz. (57 g)

* Please review the disclaimer below.