BURN - aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula officinalis, salicylicum acidum, zin

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M), ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9), ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW), BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U), CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ), SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ), ZINC SULFATE H
Available from:
MBI Distributing Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporarily relieves symptoms of minor burns, superficial scalds, sunburn, and other minor skin irritations such as: - redness - stinging - burning - itching - minor pain - dryness - as per homeopathic materia medica Aesculus hippocastanum...................................................Venous Stasis Aloe socotrina...........................................................................Redness Arnica montana...........................................................................Burning Berberis vulgaris..........................................................................Burning Calendula officinalis.....................................................................Healing Salicylicum acidum.......................................................Burning and Heat Zincum metallicum.............................................................Pain Reliever Do not - use if you are allergic to salicylates (although this product does not contain aspirin) - use in the eyes - apply over large areas of the
Authorization status:
unapproved homeopathic
Authorization number:
58301-181-28

BURN - aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula

officinalis, salicylicum acidum, zincum metallicum spray

MBI Distributing 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.

----------

Aesculus hippocastanum 4x, Aloe socotrina 4x, Arnica montana 4x, Berberis vulgaris 4x, Calendula

officinalis 4x, Salicylicum acidum 2x, Zincum metallicum 3x

deionized water, propylene glycol, polysorbate 20, glycerine, sodium bicarbonate, MSM,

Dimethylaminoethanol, citric acid, potassium sorbate, benzyl alcohol, trace minerals (trona), avocado

oil, and vitamin E

Temporarily relieves symptoms of minor burns, superficial scalds, sunburn, and other minor skin

irritations such as:

redness

stinging

burning

itching

minor pain

dryness

as per homeopathic materia medica

Directions

Adults and children 3 years of age and older:

clean the burned area(s)

apply topically as needed not more than 12 times daily

area may be covered with a sterile bandage

children under 3 years of age: consult a physician

Aesculus hippocastanum...................................................Venous Stasis

Aloe socotrina...........................................................................Redness

Arnica montana...........................................................................Burning

Berberis vulgaris..........................................................................Burning

Calendula officinalis.....................................................................Healing

Salicylicum acidum.......................................................Burning and Heat

Zincum metallicum.............................................................Pain Reliever

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

right away.

For external use only.

Questions?

1.800.321.3740

Mon-Fri, 9am-5pm

Do not

use if you are allergic to salicylates (although this product does not contain aspirin)

use in the eyes

apply over large areas of the body

use longer than 1 week unless directed by a doctor

ingest

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

When using this product

use only as directed

test on a small area before use. This product may cause allergic reaction in some individuals.

wash hands before and after using

avoid contact with eyes or mucous membranes

do not bandage tightly

Stop use and ask a doctor if

condition worsens

if symptoms persist for more than 7 days or clear up and occur again within a few days

excessive skin irritation occurs

store at room temperature

Tamper Evident: Do not use if imprinted seal around cap is broken or missing.

Tamper Evident: Do not use if imprinted seal around cap is broken or missing.

BURN

aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula officinalis, salicylicum

acidum, zincum metallicum spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 30 1-18 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AESCULUS HIPPO CASTANUM FLO WER (UNII: KK0 Z9 2II8 M) (AESCULUS

HIPPOCASTANUM FLOWER - UNII:KK0 Z9 2II8 M)

AESCULUS

HIPPOCASTANUM FLOWER

4 [hp_X]

in 6 0 mL

ALO E (UNII: V5VD430 YW9 ) (ALOE - UNII:V5VD430 YW9 )

ALOE

4 [hp_X]

in 6 0 mL

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

4 [hp_X]

in 6 0 mL

BERBERIS VULGARIS RO O T BARK (UNII: 1TH8 Q20 J0 U) (BERBERIS VULGARIS

ROOT BARK - UNII:1TH8 Q20 J0 U)

BERBERIS VULGARIS ROOT

BARK

4 [hp_X]

in 6 0 mL

CALENDULA O FFICINALIS FLO WERING TO P (UNII: 18 E7415PXQ) (CALENDULA

OFFICINALIS FLOWERING TOP - UNII:18 E7415PXQ)

CALENDULA OFFICINALIS

FLOWERING TOP

4 [hp_X]

in 6 0 mL

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

2 [hp_X]

in 6 0 mL

ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION -

UNII:13S1S8 SF37)

ZINC SULFATE

HEPTAHYDRATE

3 [hp_X]

in 6 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

AVO CADO O IL (UNII: 6 VNO72PFC1)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 30 1-18 1-28

6 0 mL in 1 BOTTLE, SPRAY

Marketing Information

MBI Distributing Inc.

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 9 /0 1/20 10

Labeler -

MBI Distributing Inc. (196786545)

Registrant -

MBI Distributing Inc. (196786545)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MBI Distributing Inc.

19 6 78 6 545

ma nufa c ture

Revised: 7/2011

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