ALOE ICE SUNBURN RELIEF JELLY

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 2g in 100mL
Labeler: Aloe Care International, LLC
NDC Code: 61477-101

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.

ACTIVE INGREDIENTS:

LIDOCAINE HYDROCHLORIDE (2%)

PURPOSE:

PAIN RELIEF

INDICATIONS:

FOR THE RELIEF OF SUNBURN PAIN.

DIRECTIONS:

APPLY GENEROUSLY TO AFFECTED AREA.

KEEP OUT OF REACH OF CHILDREN.

WARNINGS:

FOR EXTERNAL USE ONLY, NOT TO BE SWALLOWED. AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

Other Ingredients:

Aloe Barbadensis Leaf Juice, Blue 1 (CI 42090), Carbomer, Disodium EDTA, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Polysorbate 20, Propylene Glycol, Triethanolamine, Water

ALOE ICE SUNBURN RELIEF JELLY 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA WHOLE 
FD&C BLUE NO. 1 
CARBOMER 934 
EDETATE DISODIUM 
IODOPROPYNYL BUTYLCARBAMATE 
METHYLISOTHIAZOLINONE 
POLYSORBATE 20 
PROPYLENE GLYCOL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:61477-101-14120 mL in 1 TUBE
2NDC:61477-101-1160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/24/2014
Labeler - Aloe Care International, LLC (938242187)
Registrant - Aloe Care International, LLC (938242187)

Revised: 02/2014
 
Aloe Care International, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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