Acne Relief Gel

Acne Relief Gel
SPL v3
SPL
SPL Set ID 43f669ef-2ebd-46c8-adb6-84bea30a7c0b
Route
TOPICAL
Published
Effective Date 2018-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X]) Matricaria Chamomilla (2 [hp_X]) Berberis Aquifolium Root Bark (6 [hp_X]) Hamamelis Virginiana Root Bark/stem Bark Calcium Sulfide Sulfur
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Ethylhexylglycerin Glycerin Aloe Vera Leaf Phenoxyethanol Water Sodium Hydroxymethylglycinate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-11-29

Description

​Drug Facts: ​ACTIVE INGREDIENTS (HPUS*): Each 100g contains: Calendula Officinalis 1X 5g, Chamomilla 1X 3g, Berberis Aquafolium 2X 3g, Hamamelis 2X 1g, Hepar Sulph. Calc. 6X 1g, Sulphur 6X 1g. **The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States. * ​Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Warnings and Precautions

WARNINGS: FOR TOPICAL USE ONLY. DO NOT APPLY TO BROKE SKIN. KEEP OUT OF REACH OF CHILDREN. 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 healthcare professional. IF SWALLOWED, get medical help or contact a Poison Control Center right away.

Indications and Usage

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

Dosage and Administration

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

Description

​Drug Facts: ​ACTIVE INGREDIENTS (HPUS*): Each 100g contains: Calendula Officinalis 1X 5g, Chamomilla 1X 3g, Berberis Aquafolium 2X 3g, Hamamelis 2X 1g, Hepar Sulph. Calc. 6X 1g, Sulphur 6X 1g. **The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States. * ​Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

Inactive ingredients: Carbomer 980, Ethythexyglycerin, Glycerin, Organic Aloe Vera Powder, Phenoxythanol, Purified Water, Sodium Hydroxide.

Section 51945-4

NDC: 66096-747-03

ACNE RELIEF GEL

Natural - Safe - Effective

No Side Effects

Net Wt: 1.75 oz (50 g)

ohm

PHARMA

​Your Partner in Homeopathy

Section 53413-1

QUESTIONS OR COMMENTS?

Mfg. By: OHM PHARMA, INC.

Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1

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

Section 55106-9

​Drug Facts:

​ACTIVE INGREDIENTS (HPUS*): Each 100g contains: Calendula Officinalis 1X 5g, Chamomilla 1X 3g, Berberis Aquafolium 2X 3g, Hamamelis 2X 1g, Hepar Sulph. Calc. 6X 1g, Sulphur 6X 1g.

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

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

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

WARNINGS: FOR TOPICAL USE ONLY. DO NOT APPLY TO BROKE SKIN. KEEP OUT OF REACH OF CHILDREN. 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 healthcare professional. IF SWALLOWED, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

Inactive ingredients: Carbomer 980, Ethythexyglycerin, Glycerin, Organic Aloe Vera Powder, Phenoxythanol, Purified Water, Sodium Hydroxide.

Section 51945-4 (51945-4)

NDC: 66096-747-03

ACNE RELIEF GEL

Natural - Safe - Effective

No Side Effects

Net Wt: 1.75 oz (50 g)

ohm

PHARMA

​Your Partner in Homeopathy

Section 53413-1 (53413-1)

QUESTIONS OR COMMENTS?

Mfg. By: OHM PHARMA, INC.

Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

​Drug Facts:

​ACTIVE INGREDIENTS (HPUS*): Each 100g contains: Calendula Officinalis 1X 5g, Chamomilla 1X 3g, Berberis Aquafolium 2X 3g, Hamamelis 2X 1g, Hepar Sulph. Calc. 6X 1g, Sulphur 6X 1g.

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

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

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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