Injure Gel
FDA Label NDC 43406-0707

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc for the product Injure Gel (NDC 43406-0707). 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 otc - active ingredient, indications & usage, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Arnica Montana4X, 30C, Calendula Officinalis 4X, Hypericum Perf 4X, 30C, Symphytum Off 6X, Bellis Per 12X, Ledum Palustre 12X, Sulphuricum Ac 12X, Calc Fluor 30X, Ferrum Phos 30X, Rhus Tox 30X, Nat Sulphuricum 30C

Indications & Usage

USES: Temporarily relieves soreness and bruised feelings.**

Otc - Purpose

USES: Temporarily relieves soreness and bruised feelings.**

Dosage & Administration

DIRECTIONS: Apply small amount every 10 minutes for 3 doses immediately after injury. Then 2-3 times daily.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Warnings

WARNINGS:

  • FOR TOPICAL USE ONLY
  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient

INACTIVE INGREDIENTS: Carbomer 980, Ehtanol Alcohol, Glycerin USP, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxide

Otc - Questions

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Package Label.Principal Display Panel

NDC:43406-0707-5

Injure Gel

HOMEOPATHIC

 2 oz (56.7 g)

Image Description (Injuregel)

Image Description (Injuregel)

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