ALOE ICE SUNBURN RELIEF- lidocaine hydrochloride gel 
Aloe Care International, LLC

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ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)

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 1oz Finals 2017

ALOE ICE SUNBURN RELIEF 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER 934 (UNII: Z135WT9208)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61477-101-14120 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2014
2NDC:61477-101-1160 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/24/2014
Labeler - Aloe Care International, LLC (938242187)

Revised: 2/2024
Document Id: 114a5cb2-4084-3c3d-e063-6294a90a777d
Set id: 56866fa8-052e-497c-a954-978d7d628949
Version: 10
Effective Time: 20240213
 
Aloe Care International, LLC