Ohm Skin Growths (Thuja Occ., Baptisia Tinctoria, Calendula Officinalis, Hydrastis Canadensis.) Gel [Ohm Pharma Inc.] -

OHM SKIN GROWTHS (THUJA OCC., BAPTISIA TINCTORIA, CALENDULA OFFICINALIS, HYDRASTIS CANADENSIS.) GEL [OHM PHARMA INC.]
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NDC	66096-699-20
Set ID	eca586e5-7f7c-48c5-b2e4-0c3074610302
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*): Each 100g contains: Thuja Occ. 1X 2g, Baptisia Tinctoria 1X 1g, Calendula Officinalis 1X 1g, Hydrastis Canadensis 5X 1g.

* 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 scaly, rough skin with tendency to overgrowths, warts and fungal infections.**

**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.
WARNINGS
WARNINGS: FOR TOPICAL USE ONLY. DO NOT APPLY TO BROKEN SKIN. AVOID CONTACT WITH EYES. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. If symptoms worsen or persist for more than a week, discontinue use and consult a doctor. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN.
DOSAGE & ADMINISTRATION

DIRECTIONS: Apply a small amount to affected area 3 times a day or as directed by a health care professional.
OTHER SAFETY INFORMATION

OTHER INFORMATION: Do not use if TAMPER EVIDENT seal is broken or missing. Store at room temperature.
INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Carbomer 980, Glycerin, Ethyl Alcohol, Cedar Oil, Geranium Oil, Lavender Oil, Lemon Oil, Lemongrass Oil, Purified Water, Sodium Hydroxide, Tea Tree Oil.
QUESTIONS

QUESTIONS OR COMMENTS? Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com
PRINCIPAL DISPLAY PANEL

HOMEOPATHIC MEDICINE

NDC: 66096-699-20

SKIN GROWTHS GEL

Natural - Safe - Effective

No Side Effects

Net Wt: 2 oz (56.7 g)

Product of USA

Relieves scaly, rough skin.

INGREDIENTS AND APPEARANCE

OHM SKIN GROWTHS
thuja occ., baptisia tinctoria, calendula officinalis, hydrastis canadensis. gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66096-699
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	1 [hp_X] in 56.7 g
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	1 [hp_X] in 56.7 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X] in 56.7 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X] in 56.7 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 980 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LEMON OIL (UNII: I9GRO824LL)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TEA TREE OIL (UNII: VIF565UC2G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66096-699-20	56.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/23/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/23/2017

Labeler - OHM PHARMA INC. (030572478)

Registrant - OHM PHARMA INC. (030572478)

Name	Address	ID/FEI	Business Operations
Establishment
OHM PHARMA INC.		030572478	manufacture(66096-699)

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