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

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 Up Aloe Ice Jelly_Tube

ALOE ICE SUNBURN RELIEF JELLY
lidocaine hydrochloride gel

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (LIDOCAINE)	LIDOCAINE HYDROCHLORIDE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA WHOLE
FD&C BLUE NO. 1
CARBOMER 934
EDETATE DISODIUM
IODOPROPYNYL BUTYLCARBAMATE
METHYLISOTHIAZOLINONE
POLYSORBATE 20
PROPYLENE GLYCOL
TROLAMINE
WATER

#	Item Code	Package Description
Packaging
1	NDC:61477-101-14	120 mL in 1 TUBE
2	NDC:61477-101-11	60 mL in 1 TUBE

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

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)

Name	Address	ID/FEI	Business Operations
Establishment
DIVERSIFIED MANUFACTURING CORP		185073996	manufacture(61477-101), pack(61477-101)

Revised: 2/2014

Document Id: 199a7ae8-2f25-4843-8bfb-f8d55ad3ab33

Set id: 56866fa8-052e-497c-a954-978d7d628949

Version: 1

Effective Time: 20140224

Aloe Care International, LLC