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ALOE ICE SUNBURN RELIEF

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

USES

TEMPORARY PAIN ASSOCIATED WITH MINOR BURNS

DIRECTIONS

APPLY GENEROUSLY TO AFFECTED AREA.

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

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

STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR PERSISTS FOR MORE THAN 7 DAYS OR CLEARS UP AND RETURNS.

INACTIVE INGREDIENTS

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

QUESTIONS OR COMMENTS?

1-800-950-2563  *  WWW.ALOEUP.COM

ALOE ICE SUNBURN RELIEF 
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)

 
Aloe Care International, LLC

Medically reviewed on Aug 14, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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