“Dynamiclear ORO is a single application topical treatment for cold sores & fever blisters caused by herpes viruses. It has been scientifically formulated using an FDA approved Ingredient, Camphor, a pain reliever and a Patented Formula of natural ingredients that has proven Clinical efficacy against Herpes Simplex Viruses (HSV1 and HSV11). Dynamiclear ORO works by eliminating the virus on direct contact. It requires just one application per outbreak.  The Patented Formula has been Clinical Proven to provide rapid reduction in symptoms of cold sores within 24-48 hours (in typical cases *) in just a single application. Dynamiclear ORO provides quick pain relief, dries up blisters & weeping sores and can be applied at any stage of an outbreak. (*In some cases, cold sores may take up to 72hrs or longer to clear up and may require more than one application, as shown in the Clinical Study.

Allergic reactions to Dynamiclear are known to occur. If you experience any adverse reaction discontinue the use (signs and symptoms listed below).

Wash affected area with copious amount of water and seek medical attention if required.

1. Severe burning sensation or inflammation of lips.
2. Severe inflammation of Lesions or blisters and it starts to weep or bleed
3. Severe increases in pain over long period more than an hour or two.  (Note: When Dynamiclear is applied to active cold sores you may experience an imminent sharp pain that indicates the medicine is working that should subside quickly. It is not necessarily an adverse reaction)
4. Increased and excessive dryness of lips and mouth area if or when applying inside the lips (the mucosa membrane). Note: Dynamiclear should not be used inside the mouth area. Do not confuse Canker Sores with Cold Sores. Canker Sores are ulcers that appear mostly inside the mouth and the mucosa membrane inside the lips. Cold Sores mainly appears on or outside the lips

Who, When and Where not to use Dynamiclear:

1. People who are allergic to Dynamiclear. First time uses if you have hypersensitive skin or are unsure perform a patch test by applying Dynamiclear lightly under your arm (a sensitive part of your skin, wait up to 3 to 5mins, if no severe burning sensation, inflammation or pain is experienced, use as directed)
2. If pregnant seek medical advice from your Doctor or pharmacist before using Dynamiclear. Do not use during the first Trimester
3. Do not use in your eyes or mouth
4. When your doctor advises not to use Dynamiclear
5. If you are allergic to any of the ingredients in the product.
6. Children under the age of 12 should seek medical advice prior to using Dynamiclear
7. People who are immunocompromised should seek medical advice prior to using Dynamiclear.
8. People who are not sure should seek medical advice from a Pharmacist or Doctor prior to using Dynamiclear.

NDC Code(s): 49836-029-02
Packager: RX PHARMA-PACK, INC.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG LABEL INFORMATION
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ACTIVE INGREDIENT
Camphor 3%

PURPOSE
Fever blister/ cold sore treatment/ pain reliever (external analgesic)

USES
Pain relief – Relieves burning and itching – Fever blister/cold sore relief

WARNINGS

For external use only.

Ask a doctor or pharmacist before use if you have any questions about this product.

When using this product do not get into eyes.

Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

Apply a single application to each outbreak as needed. Repeat application may not be necessary. If symptoms persist over 24-hours, apply another single application.

OTHER INFORMATION:

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

STORAGE CONDITIONS

Store between 10°-25°C (50°F-77°F)
Avoid heat and direct sunlight

For the procedure pack to work properly keep the product between 10°C to 25°C). If the temperature of the product drops below 5°C the medicine may become very thick. In this case take the vial and rub between your palm of your hands until temperature increase. You will notice the cottontip applicator sliding into the product more easily. In case the medicine is not flowing through with ease, reverse insert the cotton tip applicator. Ensure one end of the applicator is fully saturated and the other end is immersed into the medicine in the glass vial)

INACTIVE INGREDIENTS
Aloe vera, calendula officinalis, cupric sulfate, glycerol, hypericum perforatum, isopropyl alcohol, polyethylene glycol, polysorbate, vitamin E

QUESTIONS OR COMMENTS?
Rx Pharma Pack 1-844-632-7898

PRINCIPAL DISPLAY PANEL
For External Use Only

TWIN PACK
(2x single application packs)
NDC# 49836-029-02

ORO – Dynamiclear™
Camphor 3%

✓ Pain Relief                 ✓ Relieves Burning
✓ Single Application      ✓ Relieves Itching

(Amount: 2x (0.75 mL Each) Single Application Swabs Per Unit Pack)

ALWAYS READ INSTRUCTIONS BEFORE USE.

1. Carefully remove cap and slowly insert cotton tip into glass vial.
2. Gently push cotton tip into the liquid. Hold onto vial. Do not remove cotton tip from vial.
3. Apply to infected area with a gentle pressure for 30 seconds then discard. Keep area dry.

Exclusive US Distributor: Rx Pharma Pack
245 Oser Avenue, Hauppauge, NY 11788

FEVER BLISTER / COLD SORE TREATMENT
(EXTERNAL ANALGESIC )

INGREDIENTS AND APPEARANCE
Product Information