ALOE ICE SUNBURN RELIEF- lidocaine hydrochloride gel

ALOE ICE SUNBURN RELIEF by

Drug Labeling and Warnings

ALOE ICE SUNBURN RELIEF by is a Otc medication manufactured, distributed, or labeled by Aloe Care International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE ICE SUNBURN RELIEF 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	2 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
1	NDC: 61477-101-14	120 mL in 1 TUBE; Type 0: Not a Combination Product	02/24/2014
2	NDC: 61477-101-11	60 mL in 1 TUBE; Type 0: Not a Combination Product	02/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/24/2014

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)