BURN- lidocaine hydrochloride and benzalkonium chloride cream
Galentic Pharma (India) Private Limited
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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ACTIVE INGREDIENT
Benzalkonium Chloride 0.13%
Lidocaine HCl 0.5%
PURPOSE
Topical antiseptic
Topical analgesic
USES
- For temporary relief of pain and itching associated with:
- sunburn
- minor burns
- insect bites
- minor skin irritation
- cuts
- scrapes
WARNINGS
For external use only.
-
Do not use
- in the eyes
- over large areas of the body or on deep puncture wounds, animal bites or serious burns
- in large quantities, particularly over raw surfaces or blistered areas
-
Stop use and ask a doctor if
- the condition gets worse
- condition clears up and recurs within a few days
- condition persists for more than 7 days
-
if pregnant or breast feeding, ask a health care professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS
Adults and children 2 years and over:
- clean the affected area
- apply a small amount of this product on the area 3 to 4 times daily
- may be covered with a sterile bandage
Children under 2 years
OTHER INFORMATION
- store in a cool, dry area 59° to 79° F (15° to 25° C)
- tamper evident sealed packets
- do not use any open or torn packets
INACTIVE INGREDIENTS
Butylated hydroxytoluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Sodium EDTA, Sodium methylparaben, Sodium propylparaben, Purified Water
Manufactured by :
Galentic Pharma (India) Pvt. Ltd.,
Plot No. 5-B & 5-C, Sector III,
Kandla Special Economic Zone,
Gandhidham-370 230, Gujarat. India
PRINCIPAL DISPLAY PANEL - 0.9 gram Packet Carton
NDC # 50382-022-12
GALENTIC
Burn Cream with Lidocaine
Antiseptic and pain relieving cream
for minor cuts, scrapes and burns
0.9 gram Packets
25 per box