NDC | 61500-0115-1 |
Set ID | e6285625-cc8f-4a07-8dc6-f9adc204c454 |
Category | HUMAN OTC DRUG LABEL |
Packager | Topical BioMedics, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- Homeopathic Active Ingredients
- Uses
-
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
-
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
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MY PAIN AWAY AFTER BURN CREAM
aesculus hippocastanum, arnica montana, belladonna, crotalus horridus, echinacea, graphites, heloderma, lachesis mutus, naja tripudians, rhus toxicodendron, ruta graveolens creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61500-0115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61500-0115-1 176 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2016 Labeler - Topical BioMedics, Inc. (125911037) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 manufacture(61500-0115)