DYNAMICLEAR ORO- glycerin swab
Sci-chem International 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
glycerin swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57261-786
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg in 0.5 mL

Ingredient Name	Strength
Inactive Ingredients
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57261-786-11	0.5 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	07/31/2015	10/18/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	11/11/2014	10/18/2016

Labeler - Sci-chem International Pty Ltd (753878391)

Name	Address	ID/FEI	Business Operations
Establishment
ACTIV PHARMACEUTICALS PTY LTD		755111275	manufacture(57261-786) , pack(57261-786) , label(57261-786)

Revised: 10/2016

Document Id: 3f268739-25d7-09be-e054-00144ff88e88

Set id: 5b599999-5af2-4771-bce9-77810db0c268

Version: 8

Effective Time: 20161018

Sci-chem International Pty Ltd