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NDC 21922-0023-18 Docosanol 100 mg/g Details

Docosanol 100 mg/g

Docosanol is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Encube Ethicals Private Limited. The primary component is DOCOSANOL.

Product Information

NDC	21922-0023
Product ID	21922-023_5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Docosanol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docosanol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/g
Substance Name	DOCOSANOL
Labeler Name	Encube Ethicals Private Limited
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA212385
Listing Certified Through	2024-12-31

Package

Package Images

NDC 21922-0023-18 (21922002318)

Pricing Information	N/A
NDC Package Code	21922-023-18
Billing NDC	21922002318
Package	1 TUBE in 1 PACKAGE (21922-023-18) / 2 g in 1 TUBE
Marketing Start Date	2022-10-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd Details

ACTIVE INGREDIENT(S)

Docosanol 10%

PURPOSE

Cold sore/fever blister treatment

USE(S)

treats cold sores/fever blisters on the face or lips
shortens healing time and duration of symptoms:
tingling, pain, burning, and/or itching

WARNINGS

Allergy alert

This product may cause a severe allergic reaction.

Syptoms may include:

hives
facial swelling
wheezing/difficulty breathing
shock
rash

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

For external use only

DO NOT USE

if you are allergic to any ingredient in this product

When using this product

apply only to affected areas
do not use in or near the eyes
avoid applying directly inside your mouth
do not share this product with anyone. This may spread infection.

STOP USE AND ASK DOCTOR IF

your cold sore gets worse or the cold sore is not healed within 10 days

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:

wash hands before and after applying cream
apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle).
early treatment ensures the best results
rub in gently but completely
use 5 times a day until healed

children under 12 years : ask a doctor

STORAGE

store at 20°-25°C (68°-77°F)

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.

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)

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)

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)

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)

INGREDIENTS AND APPEARANCE

DOCOSANOL

docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21922-023
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY)	DOCOSANOL	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21922-023-18	1 in 1 PACKAGE	10/10/2022
1		2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:21922-023-17	1 in 1 PACKAGE	10/10/2022
2		2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA212385	10/10/2022

Labeler - Encube Ethicals Private Limited (915834105)

Name	Address	ID/FEI	Business Operations
Establishment
Encube Ethicals Private Limited		725076298	ANALYSIS(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