Injure Gel

Injure Gel
SPL v1
SPL
SPL Set ID 8893c906-0dab-44ef-956b-b5427d4dbf7f
Route
TOPICAL
Published
Effective Date 2022-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (4 [hp_X]) Comfrey Root (6 [hp_X]) Bellis Perennis (12 [hp_X]) Ledum Palustre Twig (30 [hp_X]) Sulfuric Acid (30 [hp_C]) Fluoride Ion Ferrosoferric Phosphate Toxicodendron Pubescens Leaf Arnica Montana Hypericum Perforatum Sodium Sulfate Anhydrous
Inactive Ingredients
Carbomer 980 Alcohol Glycerin Aloe Vera Whole Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-08-21

Description

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


Medication Information

Warnings and Precautions

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.
Indications and Usage

USES: Temporarily relieves soreness and bruised feelings.**

Dosage and Administration

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

Description

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

Section 34093-5

*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.

Section 50565-1

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.

Section 51727-6

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

Section 51945-4

NDC:43406-0707-5

Injure Gel

HOMEOPATHIC

 2 oz (56.7 g)

Section 53413-1

QUESTIONS & COMMENTS?

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

Section 55105-1

USES: Temporarily relieves soreness and bruised feelings.**

Section 55106-9

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


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves soreness and bruised feelings.**

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.
Section 34093-5 (34093-5)

*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.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

NDC:43406-0707-5

Injure Gel

HOMEOPATHIC

 2 oz (56.7 g)

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

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

Section 55105-1 (55105-1)

USES: Temporarily relieves soreness and bruised feelings.**

Section 55106-9 (55106-9)

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


Advanced Ingredient Data


Raw Label Data

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