First Aid Antiseptic Pain Relieving: Package Insert and Label Information

FIRST AID ANTISEPTIC PAIN RELIEVING- benzalkonium chloride and lidocaine hydrochloride cream
GFA Production (Xiamen) Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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 reach 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

Package Labeling:

Pain relieving
(click image for full-size original)

FIRST AID ANTISEPTIC PAIN RELIEVING
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50814-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 g
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50814-009-01 0.9 g in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/01/2016
Labeler — GFA Production (Xiamen) Co., Ltd. (421256261)

Revised: 09/2021 GFA Production (Xiamen) Co., Ltd.

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