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

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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CVS Wound & Burn Care Refill Pack

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.

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

Burn CreamWound and Burn Care

WOUND AND BURN CARE REFILL PACK 
benzalkonium chloride, lidocaine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-401
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-401-001 in 1 BAG; Type 0: Not a Combination Product12/01/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52124-0040-10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/28/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333A12/01/2016
Labeler - CVS (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Tender Corporation064437304manufacture(69842-401)

Revised: 12/2016
Document Id: 44b9b575-b999-60a8-e054-00144ff8d46c
Set id: 44b9b575-b998-60a8-e054-00144ff8d46c
Version: 1
Effective Time: 20161228
 
CVS