Label: DOCOSANOL cream
-
NDC Code(s):
58602-019-08,
58602-019-09,
58602-019-11,
58602-019-12, view more58602-019-13, 58602-019-15, 58602-019-16, 58602-019-17, 58602-019-24
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 2, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
-
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
Other information
• store at 20° to 25°C (68° to 77°F).
• do not freeze
- Inactive ingredients
-
Additional information
*Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.
Retain this insert for full product uses, directions and warnings.
Distributed by:
AUROHEALTH LLC,
279 Princeton-Hightstown Road,
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/58039/2020
Thank you for purchasing Docosanol Cream. 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, the more effective the medicine will be. So for best results, use docosanol cream at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.
Docosanol cream is different from other over-the-counter cold sore products. Only docosanol cream 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:
How is docosanol cream different from the over-the-counter cold sore remedies I have already been using?
Docosanol cream is the only FDA approved non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using docosanol cream, the sooner you can begin healing your cold sore.
Who can use docosanol cream?
Adults and children 12 years and over can use docosanol cream.
How often can I apply docosanol cream?
Docosanol cream 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?
Yes, cosmetics such as lipstick may be applied over docosanol cream. 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.
How to use your docosanol cream Pump (for pump pack)
- For Adults and Children 12 years and older
- Docosanol cream 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. 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.
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 to 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 more information:
Call us at 1-855-274-4122
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Label 10% (2 g Tube)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Label 10% (2 g Pump)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Square Blister Card Label 10% (2 g Pump)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Clamshell Blister Card Label 10% (2 g Pump)
AUROHEALTH
#Compare to the active
Ingredient in Abreva®
NDC 58602-019-16
Docosanol Cream 10%
Cold Sore/Fever Blister Treatment
Non-Prescription Medicine to Shorten Healing Time*
Portable
Convenient
Pump
Cold Sore Treatment
For Topical Use Only
Read Inside fold out
for full details
NET WT
2 g (0.07 oz)
-
INGREDIENTS AND APPEARANCE
DOCOSANOL
docosanol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL 100 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-019-08 1 in 1 PACKAGE 03/01/2024 1 2 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58602-019-24 1 in 1 PACKAGE 03/01/2024 2 2 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:58602-019-09 2 in 1 PACKAGE 03/01/2024 3 2 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:58602-019-11 1 in 1 PACKAGE 03/01/2024 4 3 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:58602-019-12 1 in 1 PACKAGE 03/01/2024 5 3 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:58602-019-13 2 in 1 PACKAGE 03/01/2024 6 3 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:58602-019-15 1 in 1 PACKAGE 03/01/2024 7 2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 8 NDC:58602-019-16 1 in 1 PACKAGE 03/01/2024 8 2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 9 NDC:58602-019-17 2 in 1 PACKAGE 03/01/2024 9 2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217090 03/01/2024 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 878100017 ANALYSIS(58602-019) , MANUFACTURE(58602-019)