Docosanol Cream
FDA Label NDC 43598-946

15 label sections · Submitted to the FDA by Dr.reddys' Laboratories Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr.reddys' Laboratories Inc for the product Docosanol (NDC 43598-946). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Docosanol 10%

Purpose

Cold sore/fever blister treatment

Uses

  • 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. 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

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 A 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 (1-800-222-1222).

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 20o-25oC (68o-77oF)
  • do not freeze

Inactive Ingredients

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

Questions Or Comments?

call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784

Distributed By Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540

Made in India

Principal Display Panel - Carton 2 G (0.07 Oz)

NDC 43598-946-02

Docosanol Cream, 10%

Cold Sore/Fever Blister Treatment

FDA Approved Medicine to SHORTEN HEALING TIME**

NET WT

2g (0.07 oz)

Carton1s Net Wt 2g (0.07 Oz) (Carton1s)

Carton1s Net Wt 2g (0.07 Oz) (Carton1s)

Principal Display Panel - Carton 4 G (0.14 Oz)

NDC 43598-946-22

Docosanol Cream, 10%

Cold Sore/Fever Blister Treatment

FDA Approved Medicine to SHORTEN HEALING TIME**

NET WT

4 g (0.14 oz)

Carton2s Net Wt 4 G (0.14 Oz) (Carton2s)

Carton2s Net Wt 4 G (0.14 Oz) (Carton2s)

Principal Display Panel - Carton 6 G (0.21 Oz)

NDC 43598-946-13

Docosanol Cream, 10%

Cold Sore/Fever Blister Treatment

FDA Approved Medicine to SHORTEN HEALING TIME**

NET WT

6 g (0.21 oz)

Carton3s Net Wt 6 G (0.21 Oz) (Carton3s)

Carton3s Net Wt 6 G (0.21 Oz) (Carton3s)

* Please review the disclaimer below.