NDC | 66096-663-08 |
Set ID | e76d62c6-7b27-441c-9de6-1fee2611a464 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | OHM PHARMA INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
WARNINGS: FOR TOPICAL USE ONLY. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than a week, discontinue use and contact a doctor. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: Bergamot Essential Oil, Cocamide MIPA**, Cocamidopropyl Betaine**, Cocamidopropyl Hydroxysultaine**, Decyl Glucoside***, Disodium Laureth Sulfosuccinate**, Disodium Lauryl Sulfosucciante**, Magnesium Chloride (Natural Mineral), Organic Aloe Vera Gel, Purified Water, Rosemary Extract, Sesame Seed Oil, Sodium Chloride (Common Salt), Sodium Hydroxymethylglycinate (From Glycine & Amino Acid), Wheat Germ Oil. **Derived from Coconut Oil ***Derived from Corn Starch & Coconut
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OHM CALENDULA BALANCING
calendula, calc phos, kali iod, silicea, arnica, chamomilla, urtica ur. shampooProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66096-663 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 240 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 6 [hp_X] in 240 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 3 [hp_X] in 240 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6 [hp_X] in 240 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1 [hp_X] in 240 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 1 [hp_X] in 240 mL URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 1 [hp_X] in 240 mL Inactive Ingredients Ingredient Name Strength BERGAMOT OIL (UNII: 39W1PKE3JI) COCAMIDE (UNII: 3YXD33R71G) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ROSEMARY (UNII: IJ67X351P9) SESAME OIL (UNII: QX10HYY4QV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) WHEAT GERM OIL (UNII: 14C97E680P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66096-663-08 240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/23/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/23/2016 Labeler - OHM PHARMA INC. (030572478) Registrant - OHM PHARMA INC. (030572478) Establishment Name Address ID/FEI Business Operations OHM PHARMA INC. 030572478 manufacture(66096-663)