DYNAMICLEAR ORO (camphor- natural swab

Dynamiclear ORO by

Drug Labeling and Warnings

Dynamiclear ORO by is a Otc medication manufactured, distributed, or labeled by Dynamiclear Partners LLC, ACTIV PHARMACEUTICALS PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

Questions:  Dynamiclear Partners LLC.

www.dynamiclear-oro.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DYNAMICLEAR ORO 
camphor (natural) swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70955-886
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70955-886-01	0.5 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	09/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/05/2016

Labeler - Dynamiclear Partners LLC (080180754)

Establishment
Name	Address	ID/FEI	Business Operations
ACTIV PHARMACEUTICALS PTY LTD		755111275	analysis(70955-886) , manufacture(70955-886) , label(70955-886) , pack(70955-886)