DYNAMICLEAR ORO- glycerin swab 
Dynamiclear Pty Ltd

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.

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Dynamiclear ORO

Active Ingredients

Glycerol 400 mg/g

Purpose

Fever Blister/Cold Sore Treatment, Skin Protectant

Uses

  • Relieves cold sores and fever blisteres.
  • Softens crust (scabs) associated with cold sores and fever blisters.

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

Directions

 Adults and Children

12 years or older

Apply as needed
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 and Direct Sunlight.

Inactive Ingredients

aloe vera, calendula, cellulose ester, cupric sulfate, hypericum, polysorbate, purified water, vitamin E.

Dynamiclear ORO Carton
DYNAMICLEAR ORO 
glycerin swab
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57261-786
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN200 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALPHA-TOCOPHEROL 
HYPERICUM PERFORATUM 
CALENDULA OFFICINALIS WHOLE 
ALOE VERA WHOLE 
CUPRIC SULFATE 
POLYSORBATE 80 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57261-786-112 in 1 CARTON
11 mL in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34701/01/2014
Labeler - Dynamiclear Pty Ltd (752165139)
Establishment
NameAddressID/FEIBusiness Operations
Dynamiclear Pty Ltd752165139manufacture(57261-786)

Revised: 1/2014
Document Id: ac33db12-e5c4-4b0c-848f-b7604225e33f
Set id: 5b599999-5af2-4771-bce9-77810db0c268
Version: 2
Effective Time: 20140115
 
Dynamiclear Pty Ltd