MY PAIN AWAY AFTER BURN CREAM- aesculus hippocastanum, arnica montana, belladonna, crotalus horridus, echinacea, graphites, heloderma, lachesis mutus, naja tripudians, rhus toxicodendron, ruta graveolens cream
Topical BioMedics, 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.

----------

MyPainAway After Burn Cream 6oz

Homeopathic Active Ingredients

Aesculus hippocastanum 6X

Arnica montana 6X

Belladona 6X

Bellis perennis 6X

Calendula officinalis 4X

Crotalus horridus 8X

Echinacea 6X

Graphites 6X

Hypericum perforatum 6X

Lachesis mutus 8X

Naja tripudians 8X

Rhus toxicodendron 12X

Ruta graveolens 6X

Sulfur 8X

Uses

Rapid, soothing, moisturizing relief of pain associated with sunburn, wind burn, blisters, and minor burns. Also reduces scar tissue, especially post-surgical.

Purpose

Warnings

For external use only. Do not apply in eyes. Keep all medicines out of reach of children. Use only as directed, an dsee a doctor if pain persists for more than 3 days, new symptoms occur, redness or swelling could indicate a more seriouos condition. Always consult a doctor before beginning a self-help regimen if you are taking prescription medicine. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously 3-4 times daily or more often as needed, 3 inches on and around sunburn/burn area. Gently massage in until absorbed. Odorless, soothing, and moisturizing.

Inactive Ingredients

Captex 300 (from coconut fatty acids), Carbopol® Ultrez 10 (from sucrose), Cetyl Alcohol (from coconut oil), Spectrastat G 2 (derived from coconut), Glycerine (vegetable-based), Hydrokote (palm kernel oil with lecithin), Isopropyl Myristate emollient (from palm seeds), Lipomulse (from coconut fatty acids), Purified Water, Sodium hydroxide, Steareth-21 (from stearic acid cocoa butter)

Other Information

Store at 15º to 30ºC (50º to 86ºF). Tamper Evident. Do not use if seal is broken or tube is open. If not completely satisfied within 30 days, return to the point of purchase with receipt for a full refund.

Principal Display Panel

NDC# 61500-0115-1

Patent Pending Formula

Homeopathic

Contains Arnica & More

MyPainAway™

AFTER BURN CREAM

SOOTHES THE PAIN AND DISCOMFORT ASSOCIATED WITH:

SUNBURN

WIND BURN

BLISTERS

MINOR BURNS

3% of all Burn Cream sales go to Burn Centers

Net wt. 6 oz.

PDP

MY PAIN AWAY AFTER BURN CREAM
aesculus hippocastanum, arnica montana, belladonna, crotalus horridus, echinacea, graphites, heloderma, lachesis mutus, naja tripudians, rhus toxicodendron, ruta graveolens cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61500-0115
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X] in 88 mL
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956)	CROTALUS HORRIDUS HORRIDUS VENOM	8 [hp_X] in 88 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	6 [hp_X] in 88 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	6 [hp_X] in 88 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	6 [hp_X] in 88 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	8 [hp_X] in 88 mL
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	8 [hp_X] in 88 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_X] in 88 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	6 [hp_X] in 88 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X] in 88 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X] in 88 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	4 [hp_X] in 88 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	8 [hp_X] in 88 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X] in 88 mL

Ingredient Name	Strength
Inactive Ingredients
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61500-0115-1	176 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2016	11/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/01/2016	11/01/2022

Labeler - Topical BioMedics, Inc. (125911037)

Name	Address	ID/FEI	Business Operations
Establishment
Ultra Seal Corporation		085752004	pack(61500-0115)

Revised: 1/2023

Document Id: f19b136f-84eb-5c32-e053-2a95a90a0a83

Set id: e6285625-cc8f-4a07-8dc6-f9adc204c454

Version: 8

Effective Time: 20230106

Topical BioMedics, Inc.