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NDC 71589-0019-01 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 Aleor Dermaceuticals Limited. The primary component is DOCOSANOL.
Product Information
NDC | 71589-0019 |
---|---|
Product ID | 71589-019_79d7df50-7ce1-4679-b638-224ae611969c |
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 | Aleor Dermaceuticals Limited |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA215839 |
Listing Certified Through | 2023-12-31 |
Package
Package Images


NDC 71589-0019-01 (71589001901)
NDC Package Code | 71589-019-01 |
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Billing NDC | 71589001901 |
Package | 1 TUBE in 1 PACKAGE (71589-019-01) / 2 g in 1 TUBE |
Marketing Start Date | 2022-05-03 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 952520e5-dfc9-4946-941c-08560ce3d957 Details
Uses
WARNINGS
This product may cause a severe allergic reaction. Symptoms 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
- apply only to the 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 the infection.
- your cold sore gets worse or the cold sore is not healed within 10 days
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 the 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
Inactive ingredient
PRINCIPAL DISPLAY PANEL
Tube pack
NDC 71589-019-01
Docosanol Cream, 10%
Compare to the active ingredient in Abreva®**
Cold Sore/Fever Blister Treatment
Non-prescription Medicine to Shorten Healing Time*
Cold Sore Treatment
For Topical Use Only
NET WT 2g (0.07 oz)
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
*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
Manufactured for:
Aleor Dermaceuticals Ltd.,
Karakhadi, Vadodara 391450, India.

NDC 71589-019-03
Docosanol Cream, 10%
Compare to the active ingredient in Abreva®**
Cold Sore/Fever Blister Treatment
Non-prescription Medicine to Shorten Healing Time*
Cold Sore Treatment
For Topical Use Only
NET WT 2g (0.07 oz)
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
*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
Manufactured for:
Aleor Dermaceuticals Ltd.,
Karakhadi, Vadodara 391450, India.

INGREDIENTS AND APPEARANCE
DOCOSANOL
docosanol cream |
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Labeler - Aleor Dermaceuticals Limited (871411532) |
Registrant - Aleor Dermaceuticals Limited (871411532) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aleor Dermaceuticals Limited | 871411532 | MANUFACTURE(71589-019) , ANALYSIS(71589-019) |