WOUND AND BURN CARE REFILL PACK- benzalkonium chloride, lidocaine hcl kit

Wound and Burn Care Refill Pack by

Drug Labeling and Warnings

Wound and Burn Care Refill Pack by is a Otc medication manufactured, distributed, or labeled by CVS, Tender Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%

Purpose

First aid antiseptic, external analgesic

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with:

Minor Cuts

Scrapes

Burns

Warnings

For external use only

Do Not Use

Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week

Do not use:
in the eyes or apply over large areas of the body.
longer than 1 week unless directed by a doctor.
in large quantities, particularly over raw surfaces or blistered areas.

Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

When using this product, avoid contact with the eyes.

Stop Use

Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days
condition clears up and occurs again within a few days

Keep Out of Reach of Children

Keep out of reach of Children.

If ingested, contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older

clean affected area.

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

children under 2 years of age: consult a doctor

Storage and Handling

Other Information:

Store at room temperature (do not freeze).

Taper evident sealed packets.

Do not use packet if opened or torn.

Inactive Ingredients

Peregal-O

Glycerin monostearate

Glycerol

Purified Water.

PRINCIPAL DISPLAY PANEL

Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid

GFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

INGREDIENTS AND APPEARANCE

WOUND AND BURN CARE REFILL PACK 
benzalkonium chloride, lidocaine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-401

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-401-00	1 in 1 BAG; Type 0: Not a Combination Product	12/01/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 PACKET	2 g  in .9

Part 1 of 1

GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
benzalkonium chloride, lidocaine cream

Product Information
Item Code (Source)	NDC: 52124-0040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0040-1	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	12/01/2016

Labeler - CVS (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Tender Corporation		064437304	manufacture(69842-401)