Label: 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
- NDC Code(s): 43406-0707-5
- Packager: Natural Creations, Inc
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 21, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTIONS
- REFERENCES
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
INJURE GEL
arnica montana, calendula officinalis, hypericum perf, symphytum off, bellis per, ledum palustre, sulphuricum ac, calc fluor, ferrum phos, rhus tox, nat sulphuricum gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0707 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength CARBOMER 980 (UNII: 4Q93RCW27E) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA WHOLE (UNII: KIZ4X2EHYX) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0707-5 56.7 g in 1 TUBE; Type 0: Not a Combination Product 08/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/21/2019 Labeler - Natural Creations, Inc (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc 030572478 manufacture(43406-0707)