DynamiClear 44-475-Delisted

DynamiClear by

Drug Labeling and Warnings

DynamiClear by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DYNAMICLEAR ORO- camphor solution 
L.N.K. International, Inc.

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.

----------

DynamiClear 44-475-Delisted

Active ingredient

Camphor 3%

Purpose

Fever blister/cold sore treatment/
external analgesic

Uses

for the temporary relief of pain and itching associated with fever blisters and cold sores

Warnings

For external use only
Flammable: Keep away from fire or flame.

When using this product

avoid contact with eyes.

Stop use and ask a doctor if

• condition worsens
  
• symptoms persist for 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 right away.

Directions

• adults and children 12 years and over: single application
• children 2 to under 12 years: single application; use under adult supervision only
• children under 2 years: consult a doctor

Apply a single application to each outbreak. If symptoms persist, apply another single application after 24 hours.

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• avoid heat and direct sunlight
  

Inactive ingredients

aloe vera, calendula officinalis, cupric sulfate, glycerin, hypericum perforatum, isopropyl alcohol, polyethylene glycol, polysorbate, vitamin E

Questions or comments?

1-800-426-9391

Principal display panel

ORO
DynamiClear®

FEVER BLISTER / COLD SORE TREATMENT
(EXTERNAL ANALGESIC)

Camphor 3%

Contains 2 Treatment Vials - 0.02 fl oz (0.55 mL) per pack
†Individual results may vary.

APPLY AT ANY STAGE: TINGLE REDNESS BUMP ITCH BLISTER

Rapid Relief of Symptoms†
Relieves Itching and Pain
Easy to use Applicator

FOLDS of HONOR*

DUE TO THE NATURE OF THE PRODUCT CONTAINING HERBAL EXTRACTS SOME SEDIMENTS MAY BE VISIBLE.

*A portion of the proceeds from each sale will be donated to FoldsofHonor.org

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

NDC: 50844-475-24

Topical Use Only
Cold Sore Treatment

For more information:  www.dynamiclearoro.com

ALWAYS READ INSTRUCTIONS BEFORE USE.

1. Remove glass vial and applicator from one pack. Remove plastic cap from vial and safely discard.

2. Slowly insert applicator into vial until liquid appears at the top end. DO NOT REMOVE the applicator
    from the vial. The top of the applicator should be wet with product before applying.

3. Hold the glass vial and apply liquid by touching applicator to each cold sore outbreak with a gentle
    pressure for at least 30 seconds. Keep area dry for 5 minutes.

Distributed by:
LNK International, Inc.
Hauppauge, NY 11788

Patented & Trademark of Sci-chem International Pty Ltd.

DynamiClear 44-475

DYNAMICLEAR  ORO
camphor solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-475
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	17.326 mg  in .55 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
GLYCERIN (UNII: PDC6A3C0OX)
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Product Characteristics
Color	blue (Clear greenish blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-475-24	2 in 1 CARTON	02/25/2022	11/23/2022
1		1 in 1 PACKAGE
1		.55 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/25/2022	11/23/2022

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(50844-475) , pack(50844-475)

Revised: 11/2022

Document Id: b39999c1-44fb-4178-a77e-ae643c46dfe6

34390-5

Set id: 6b89829e-8277-444a-8bb2-307e576f3b9b

Version: 3

Effective Time: 20221123