ORO Dynamiclear by RX PHARMA-PACK, INC. ORO Dynamiclear

Drug Details [pdf]

ORO DYNAMICLEAR- camphor liquid
RX PHARMA-PACK, 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.

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ORO Dynamiclear

Drug Facts

Active ingredient

Purpose

Camphor 3% 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	use under adult supervision only
children under 2 years	consult a doctor

Apply a single application to each outbreak as needed. If symptoms persist over 24-hours, apply
another single application.

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, glycerol, hypericum perforatum, isopropyl alcohol, polyethylene glycol, polysorbate, vitamin e

Questions or comments?

Rx Pharma-Pack, Inc. 1-844-632-7898

www.dynamiclear.com

Drug Facts Box Layout

PRINCIPAL DISPLAY PANEL

DYNAMI CLEAR

ORO DYNAMICLEAR
camphor liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49836-036
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.0198 g in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 49836-036-02	1 in 1 CARTON	09/01/2020
1		0.66 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/01/2020	07/08/2021

Labeler - RX PHARMA-PACK, INC. (962149634)

Revised: 7/2021

Document Id: 47b4baeb-16d9-4af0-babc-081efd37bf55

Set id: d8db575d-4c16-4a62-b03d-f8e0a75f0846

Version: 2

Effective Time: 20210708