Injure Gel

INJURE GEL- arnica montana, calendula officinalis, hypericum perf, symphytum off, bellis per, ledum palustre, sulphuricum ac, calc fluor, ferrum phos, rhus tox, nat sulphuricum gel
Natural Creations, Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Injure Gel

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

USES: Temporarily relieves soreness and bruised feelings.**

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

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:

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

QUESTIONS & COMMENTS?

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

*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.

NDC:43406-0707-5

Injure Gel

HOMEOPATHIC

2 oz (56.7 g)

image description

INJURE GEL
arnica montana, calendula officinalis, hypericum perf, symphytum off, bellis per, ledum palustre, sulphuricum ac, calc fluor, ferrum phos, rhus tox, nat sulphuricum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43406-0707
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	4 [hp_X] in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X] in 1 g
BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS WHOLE	12 [hp_X] in 1 g
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	RHODODENDRON TOMENTOSUM LEAFY TWIG	12 [hp_X] in 1 g
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF)	SULFURIC ACID	12 [hp_X] in 1 g
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	30 [hp_X] in 1 g
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	30 [hp_X] in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_X] in 1 g
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	30 [hp_C] in 1 g
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM WHOLE	30 [hp_C] in 1 g
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	30 [hp_C] in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 980 (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43406-0707-5	56.7 g in 1 TUBE; Type 0: Not a Combination Product	08/21/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/21/2019

Labeler - Natural Creations, Inc (018022074)

Name	Address	ID/FEI	Business Operations
Establishment
OHM Pharma, Inc		030572478	manufacture(43406-0707)