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 Spray
(click image for full-size original)

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.

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