Refill 3 Cream
FDA Label NDC 49687-0017

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cmc Group Inc. for the product Refill 3 (NDC 49687-0017). 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 ingredients, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reah of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

First aid antiseptic

Pain relieving cream

Uses

  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes

Warnings

For external use only.

Do Not Use

• in the eyes  • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

• deep or puncture wounds • animal bites • serious burns.

Stop Use And Ask A Doctor If

• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out Of Reah Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the affected area
  • Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
  • Children under 2 years of age: consult a doctor
  • May be covered with a sterile bandage

Other Information

Store at room temperature

Inactive Ingredients

glycerin monostearate, glycerol, purified water

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