Burn Aide: Homeopathic Product Information

BURN AIDE- calendula officinalis flowering top, hypericum perforatum whole, arsenic trioxide, atropa belladonna, lytta vesicatoria, causticum, potassium dichromate, picric acid and urtica urens whole spray
Energique, 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.

ACTIVE INGREDIENTS:

(in each drop): 8.31% of Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Hypericum Perforatum 30X, Kali Bichromicum 12X, Picricum Acidum 12X, Urtica Urens 12X; 1.75% of Calendula Officinalis 1X, Hypericum Perforatum 1X.

PURPOSE:

May temporarily relieve itching, pain, and swelling associated with minor burns.**

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

USES:

May temporarily relieve itching, pain, and swelling associated with minor burns.**

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

WARNINGS:

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Spray on affected area as needed. Shake well before using.

INACTIVE INGREDIENTS:

Water, Ethanol, Glycerin, Aloe vers leaf juice extract, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 alkyl acrylate crosspolymer, Disodium EDTA, Sodium hydroxide.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

BURN AIDE

SPRAY

6 fl. OZ. (180 ml)

BURN AIDE calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, kali bichromicum, picricum acidum, urtica urens spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0662 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 1 mL HYPERICUM PERFORATUM WHOLE (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM WHOLE 1 [hp_X] in 1 mL ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 12 [hp_X] in 1 mL LYTTA VESICATORIA (LYTTA VESICATORIA) LYTTA VESICATORIA 12 [hp_X] in 1 mL CAUSTICUM (CAUSTICUM) CAUSTICUM 12 [hp_X] in 1 mL POTASSIUM DICHROMATE (DICHROMATE ION) POTASSIUM DICHROMATE 12 [hp_X] in 1 mL PICRIC ACID (PICRIC ACID) PICRIC ACID 12 [hp_X] in 1 mL URTICA URENS WHOLE (URTICA URENS) URTICA URENS WHOLE 12 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN WATER ALOE VERA LEAF BENZYL ALCOHOL ETHYLHEXYLGLYCERIN TOCOPHEROL CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETATE DISODIUM ANHYDROUS SODIUM HYDROXIDE ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:44911-0662-1 180 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/18/2022

Labeler — Energique, Inc. (789886132)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (44911-0662), api manufacture (44911-0662), label (44911-0662), pack (44911-0662)

Revised: 11/2022 Energique, Inc.