OHM CALENDULA BALANCING- calendula, calc phos, kali iod, silicea, arnica, chamomilla, urtica ur. shampoo

OHM Calendula Balancing by

Drug Labeling and Warnings

OHM Calendula Balancing by is a Homeopathic medication manufactured, distributed, or labeled by OHM PHARMA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS (HPUS*): Calendula 1X 1.5%, Calc Phos 6X 1%, Kali Iod 3X 1%, Silicea 6X 1%, Arnica 1X 0.5%, Chamomilla 1X 0.5%, Urtica UR 1X 0.5%.

​*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE

USES: Temporarily relieves sensitive scalp. Promotes hair restoration and improves circulation to hair follicles.†

​†This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

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.

• ​KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

DIRECTIONS: Apply shampoo to wet hair, massage for 1 minute to stimulate the scalp. For better results keep the shampoo on for at least 2 minutes before rinsing thoroughly. Repeat if desired.

OTHER SAFETY INFORMATION

OTHER INFORMATION: TAMPER EVIDENT - Do not use if seal is broken or missing. Store at room temperature, in dark, cool place, away from direct sunlight.

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

QUESTIONS OR COMMENTS? Mfg. by: OHM PHARMA, INC. / Mineral Wells, TX 76067 / www.ohmpharma.com

PRINCIPAL DISPLAY PANEL

NDC: 66096-663-08

OHM CALENDULA Balancing Shampoo

TOPICAL HOMEOPATHIC

8 fl oz (240 mL)

• Balanced pH
• Biodegradable
• Parabens Free
• Propylene Glycol Free
• Sodium Lauryl Sulfate Free
• Synthetic Fragrance Free
• Vegan - No Animal Ingredients

Relieves sensitive scalp.

INGREDIENTS AND APPEARANCE

OHM CALENDULA BALANCING 
calendula, calc phos, kali iod, silicea, arnica, chamomilla, urtica ur. shampoo

Product 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)