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Dynamiclear ORO

Medically reviewed on August 29, 2016.

Dosage form: swab
Ingredients: CAMPHOR (NATURAL) 0.15mg in 1g
Labeler: Dynamiclear Partners LLC
NDC Code: 70955-886

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 ORO

Active Ingredients

Camphor 3%

Purpose

Fever Blister/

Cold Sore Treatment

External Analgesic

Uses

Pain Relief

Relieves Burning and Itching

Fever Blister/Cold Sore Relief

Warnings

For External Use Only

In case of overdose, get medical help or contact a Poison Control Center right away.

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 breastfeeding ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact poison control center right away.

Directions

 Adults and Children

12 years and older

 Single Application

 Children under 12

 Use under adult

supervision only

 Children under 2

years

 Do not use consult

a physician

Apply a single application to each outbreak as needed.

Repeat application may not be necessary.  If symptoms

persist over 24hr apply another single application.

Other Information:

A slight sting may be felt when applying at blistered stage.

When applying to active blisters the scab occasionally turns dark before falling off within a few days.

Store at 15-30C (59-86F) Away from Heat & Direct Sunlight.

Inactive Ingredients:

glycerol, isopropyl alcohol, polyethylene glycol, cupric sulfate, polysorbate, vitamin e, calendula officinalis, hypericum perforatum, aloe vera

Questions:  Dynamiclear Partners LLC.

www.dynamiclear-oro.com

DYNAMICLEAR ORO 
camphor (natural) swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70955-886
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)0.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
CUPRIC SULFATE 
ALOE VERA LEAF 
POLYETHYLENE GLYCOL 400 
ISOPROPYL ALCOHOL 
POLYSORBATE 80 
ALPHA-TOCOPHEROL 
HYPERICUM PERFORATUM FLOWER 
CALENDULA OFFICINALIS FLOWER 
Packaging
#Item CodePackage Description
1NDC:70955-886-010.5 g in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/05/2016
Labeler - Dynamiclear Partners LLC (080180754)
Establishment
NameAddressID/FEIOperations
ACTIV PHARMACEUTICALS PTY LTD755111275analysis(70955-886), manufacture(70955-886), label(70955-886), pack(70955-886)

 
Dynamiclear Partners LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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