OHM ACNE RELIEF- calendula officinalis, chamomilla, hamamelis virginiana, hepar sulphuris calcareum, sulphur. gel
OHM PHARMA INC.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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OHM Acne Relief Gel

ACTIVE INGREDIENTS (HPUS*): Calendula Officinalis 1X 5%, Chamomilla 1X 3%, Hamamelis Virginiana 2X 1%, Hepar Sulphuris Calcareum 6X 1%, Sulphur 6X 1%.

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

USES: Temporarily relieves pimples, blemishes, redness and swelling due to simple acne. Promotes natural skin healing.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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. IF SWALLOWED, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN.

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

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

INACTIVE INGREDIENTS: Carbomer 940, Glycerin, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxymethylglycinate.

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

HOMEOPATHIC MEDICINE

NDC: 66096-169-03

ACNE RELIEF GEL

Natural - Safe - Effective

No Side Effects

tube label

Acne Relief

OHM ACNE RELIEF
calendula officinalis, chamomilla, hamamelis virginiana, hepar sulphuris calcareum, sulphur. gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66096-169
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X] in 50 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	1 [hp_X] in 50 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	2 [hp_X] in 50 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_X] in 50 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_X] in 50 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66096-169-03	50 g in 1 TUBE; Type 0: Not a Combination Product	02/22/2016	11/29/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/22/2016	11/29/2018

Labeler - OHM PHARMA INC. (030572478)

Registrant - OHM PHARMA INC. (030572478)

Name	Address	ID/FEI	Business Operations
Establishment
OHM PHARMA INC.		030572478	manufacture(66096-169)

Revised: 11/2018

Document Id: 10685c29-3fad-453d-99e0-0221d7ad23aa

Set id: 4ef25c7f-8adc-4c15-87d0-a8a02a535553

Version: 2

Effective Time: 20181129

OHM PHARMA INC.