DERMA ICE BURN RELIEF WITH ALOE VERA- lidocaine solution 
Derma Ice LLC

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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After Bite The Itch Eraser Xtra

DERMA ICE BURN RELIEF with Aloe Vera

Drug Facts

Active Ingredient

Lidocaine 1%

Purpose

External Analgesic

Uses

for the temporary relief of pain associated with

  • minor burns
  • sunburn

Warnings

For external use only. Avoid contact with eyes.

Do Not Use

  • in large quantities, particularly over raw surfaces or blistered areas
  • for serious burns

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding

ask a health 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 of age and older:
Apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years of age:
Consult a physician.

Inactive Ingredients

  Aloe Vera Flakes, Diammonium Phosphate, Hydroxyethyl Cellulose, Monoammonium Phosphate, Urea, Water

Dist. by Derma Ice, LLC

PO Box 3284 Belfair WA 98528

www.dermaice.com

Made in the USA

DERMA ICE BURN RELIEF with Aloe Vera 4 FL OZ/118 ML (51954-100-04) | DERMA ICE BURN RELIEF with Aloe Vera .125 FL OZ/3.69 ML (51954-100-00)

DERMA ICE

BURN RELIEF

          with Aloe Vera

Soothing

Topical Analgesic

For Nearly Any Minor Burn...

At Work or Play

Sun, Kitchen, Shop, Car, Jobsite

See inside flap for Drug Facts

4 FL OZ (118 ML)

DERMA ICE

BURN RELIEF

          with Aloe Vera

Soothing

Topical Analgesic

For Nearly Any Minor Burn...

At Work or Play

Sun, Kitchen, Shop, Car, Jobsite

See inside flap for Drug Facts

.125oz

Label

DERMA ICE BURN RELIEF WITH ALOE VERA 
lidocaine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51954-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
AMMONIUM PHOSPHATE, DIBASIC 
POWDERED CELLULOSE 
UREA 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51954-100-04118 mL in 1 BOTTLE
2NDC:51954-100-003.69 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/20/201103/18/2015
Labeler - Derma Ice LLC (078887562)

Revised: 3/2015
Document Id: 73f71453-91b8-4adc-b36e-a18d94210227
Set id: d4a7f246-e408-43a5-83ec-ac1af8dcf536
Version: 6
Effective Time: 20150318
 
Derma Ice LLC