BURN RELIEF- arsenic trioxide, atropa belladonna, lytta vesicatoria, causticum, picric acid, urtica urens, hypericum perforatum spray

BURN RELIEF by

Drug Labeling and Warnings

BURN RELIEF by is a Homeopathic medication manufactured, distributed, or labeled by Natrural Creations, Inc., Ohm Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (HPUS*): Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Picricum Acidum 12X, Urtica Urens 12X, Hypericum Perforatum 30C.

PURPOSE

Uses:  For the temporary relief of sunburns, burns, and itching skin.**

INDICATIONS & USAGE

Uses: For the temporary relief of sunburns, burns, and itching skin.**

DOSAGE & ADMINISTRATION

Directions:  Spray topically as needed or as directed by a health care professional.

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 EXTERNAL 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 no use if TAMPER EVIDENT seal is broken or missing.​​​​​​

INACTIVE INGREDIENT

Inactive Ingredients:  Calendula (Marigold Flowering Tops) Extract, Carbomer 940, Ethyl Alcohol USP, Glycerin USP, Hypericum Perforatum (St. John's Wort) Extract, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxymethylglycinate.

QUESTIONS

Questions & Comments?

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

REFERENCES

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

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

PRINCIPAL DISPLAY PANEL

NDC:  43406-0631-2

BURN RELIEF SPRAY

HOMEOPATHIC

2 fl  oz (60 mL) / 12% Alcohol

 UPC:  877730004758

INGREDIENTS AND APPEARANCE

BURN RELIEF 
arsenic trioxide, atropa belladonna, lytta vesicatoria, causticum, picric acid, urtica urens, hypericum perforatum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43406-0631
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	12 [hp_X]  in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X]  in 1 mL
PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S)	PICRIC ACID	12 [hp_X]  in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	12 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43406-0631-2	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/30/2016

Labeler - Natrural Creations, Inc. (018022074)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Pharma, Inc.		030572478	manufacture(43406-0631)