DOCOSANOL - docosanol cream 
Encube Ethicals Private Limited

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DOCOSANOL 10% CREAM

ACTIVE INGREDIENT(S)

Docosanol 10%

PURPOSE

Cold sore/fever blister treatment

USE(S)

WARNINGS

Allergy alert

This product may cause a severe allergic reaction.

Syptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

For external use only

DO NOT USE

When using this product

STOP USE AND ASK DOCTOR IF

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 or over:

children under 12 years : ask a doctor

STORAGE

do not freeze

INACTIVE INGREDIENTS

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate and sucrose stearate

QUESTIONS OR COMMENTS?

call toll-free 1-833-285-4151 from Monday to Friday between 9 am to 6.30 pm

Manufactured by:

Encube Ethicals Private Limited

Plot No. C1,Madkaim Industrial Estate, Madkaim,

Post: Mardol, Ponda, Goa – 403 404, India

Distributed by:

Encube Ethicals, Inc.

200 Meredith Avenue, Suite 101A

Durham, NC 27713, USA

Thank you for purchasingDocosanol Cream, 10%. We hope that since Docosanol Cream shortens the healing time of cold sores, it helps you look and feel better faster. Please follow insert directions for proper use and refer to the information below.

You are not alone

An estimated one-in-five Americans is affected by cold sores each year. Most people who experience them get two to three cold sore outbreaks each year. Just before and during an outbreak, the cold sore infection can be easily passed on to others. It is especially important to be aware of early warning signs that a cold sore is coming, and to be sure to avoid close physical contact when you have one.

Getting to the Root of the Problem

A blister, or cluster of blisters around your mouth, is caused by the cold sore virus. After the cold sore has healed, the virus stays dormant in your body but can be reactivated by everyday triggers like stress, sunlight, extreme hot or cold weather, colds and flu, lack of sleep, or menstruation.

The Sooner, the Better

A typical cold sore outbreak can last as long as seven to ten days. The sooner you begin using Docosanol Cream, 10%, the more effective the medicine will be. So for best results, use Docosanol Cream, 10% at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.

Docosanol Cream, 10% is different from other over-the-counter cold sore products. Only Docosanol Cream, 10% contains 10% docosanol, which helps to shorten the healing time of cold sores and the duration of symptoms including tingling, pain, itching and burning.


FREQUENTLY ASKED QUESTIONS:

For Pump Bottle

How to use your Docosanol Cream, 10% Pump

- Adults and children 12 years and over can use Docosanol Cream, 10%.
- Docosanol Cream, 10% should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.
- If you wish, you can apply cosmetics such as lipstick over Docosanol Cream, 10%. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying Docosanol Cream, 10%.

Press Pump completely about 6-8 times to get first dose.

Steps


STEP 1 – Wash your hands before and after treating the cold sore.

STEP 2 – Remove cap and press pump firmly. When first used, expect to press pump completely about 6-8 times before obtaining first dose.

STEP 3 – Rub in gently but completely 5 times a day until healed for maximum of 10 days.

STEP 4 – Place cap back on pump after each use.

For Tube

Who can use Docosanol Cream, 10%?

Adults and children 12 years and over can use Docosanol Cream, 10%.

How often can I apply Docosanol Cream, 10%?

Docosanol Cream, 10% should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.


Can I apply cosmetics on top of Docosanol Cream, 10%?

Yes, cosmetics such as lipstick may be applied over Docosanol Cream, 10%. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying Docosanol Cream, 10%.


PRINCIPAL DISPLAY PANEL

For Pump Bottle  - Carton Label 
NDC 21922-023-17  
DOCOSANOL 10% CREAM  
Cold Sore/Fever Blister Treatment  
Only FDA Approved to Shorten Healing Time*  
Cold Sore Treatment 
NET WT  
2g (0.07oz)


draft-pump-bottle-carton-label

draft-pump-bottle-carton-label-Panel-1




draft-pump-bottle-carton-label-Panel-2-3


draft-pump-bottle-carton-label-Panel-4



For Pump Bottle  - Bottle Label 
NDC 21922-023-17  
DOCOSANOL 10% CREAM  
Cold Sore/Fever Blister Treatment  
Only FDA Approved to Shorten Healing Time*  
Cold Sore Treatment 
NET WT  
2g (0.07oz)


draft-pump-bottle-label


For Tube - Carton
NDC 21922-023-18
DOCOSANOL 10% CREAM
Cold Sore/Fever Blister Treatment
Only FDA Approved to Shorten Healing Time*
Cold Sore Treatment
NET WT
2g (0.07 oz)


draft-tube-carton-label


draft-tube-carton-label-Panel-1


draft-tube-carton-label-Panel-2-3



draft-tube-carton-label-Panel-4



For Tube
NDC 21922-023-18
DOCOSANOL 10% CREAM
Cold Sore/Fever Blister Treatment
Only FDA Approved to Shorten Healing Time*
Cold Sore Treatment
NET WT
2g (0.07 oz)


draft-tube-label


DOCOSANOL 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21922-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCROSE DISTEARATE (UNII: 33X4X4B90S)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21922-023-181 in 1 PACKAGE10/10/2022
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:21922-023-171 in 1 PACKAGE10/10/2022
22 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21238510/10/2022
Labeler - Encube Ethicals Private Limited (915834105)
Establishment
NameAddressID/FEIBusiness Operations
Encube Ethicals Private Limited725076298ANALYSIS(21922-023) , LABEL(21922-023) , MANUFACTURE(21922-023) , PACK(21922-023)

Revised: 10/2022
Document Id: 5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd
Set id: 5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd
Version: 1
Effective Time: 20221017
 
Encube Ethicals Private Limited