NDC Code(s) : 61477-101-14, 61477-101-11
Packager : Aloe Care International, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALOE ICE SUNBURN RELIEFLIDOCAINE HYDROCHLORIDE GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61477-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE(UNII: V13007Z41A)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1NDC:61477-101-14120 mL in 1 TUBE Type 0: Not a Combination Product24/02/2014
2NDC:61477-101-1160 mL in 1 TUBE Type 0: Not a Combination Product24/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 02/24/2014

LABELER - Aloe Care International, LLC(938242187)

PRINCIPAL DISPLAY PANEL

Aloe Ice 1oz Finals 2017