NDC | 66096-693-10 |
Set ID | c12e6706-37f0-4900-856c-fc7e7ac3b724 |
Category | HUMAN OTC DRUG LABEL |
Packager | OHM PHARMA INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS (HPUS*): Calendula Officinalis 1X 3.5%, Stellaria Media 1X 1.25%, Calcarea Sulphurica 3X 1%, Chamomilla 1X 1%, Echinacea Angustifolia 1X 1%, Silicea 3X 1%, Symphytum Officinale 6X 1%, Thiosinamium 3X 1%, Hamamelis Virginiana 1X 0.25%.
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
- INDICATIONS & USAGE
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WARNINGS
WARNINGS: FOR TOPICAL USE ONLY. DO NOT APPLY TO BROKEN SKIN. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than 5 days, discontinue use and contact a health care professional. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OHM SKIN HEALING CREAM
calendula officinalis, stellaria media, calcarea sulphurica, chamomilla, echinacea angustifolia, silicea, symphytum officinale, thiosinamium, hamamelis virginiana. creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66096-693 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 96.5 g STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA 1 [hp_X] in 96.5 g CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 3 [hp_X] in 96.5 g MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 1 [hp_X] in 96.5 g ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 1 [hp_X] in 96.5 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 3 [hp_X] in 96.5 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 96.5 g ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA 3 [hp_X] in 96.5 g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X] in 96.5 g Inactive Ingredients Ingredient Name Strength SODIUM BORATE (UNII: 91MBZ8H3QO) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYSORBATE 60 (UNII: CAL22UVI4M) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCONUT OIL (UNII: Q9L0O73W7L) SUNFLOWER OIL (UNII: 3W1JG795YI) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66096-693-10 96.5 g in 1 TUBE; Type 0: Not a Combination Product 11/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/15/2016 Labeler - OHM PHARMA INC. (030572478) Registrant - OHM PHARMA INC. (030572478) Establishment Name Address ID/FEI Business Operations OHM PHARMA INC. 030572478 manufacture(66096-693)