First Aid Antiseptic Pain Relieving Cream

First Aid Antiseptic Pain Relieving by

Drug Labeling and Warnings

First Aid Antiseptic Pain Relieving by is a Otc medication manufactured, distributed, or labeled by GFA Production (Xiamen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIRST AID ANTISEPTIC PAIN RELIEVING- benzalkonium chloride, 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.

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First Aid Antiseptic Pain Relieving Cream

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:

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-009-01	0.9 g in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2016

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: 2/2018

Document Id: 6622f28e-f556-d633-e053-2991aa0ae0ac

34390-5

Set id: f61ee175-440d-4234-a181-675ba9ddb03a

Version: 5

Effective Time: 20180226