WESTERN FAMILY ALOE VERA MOISTURIZING - lidocaine hydrochloride gel 
WESTERN FAMILY FOODS, INC.

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.

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Drug Facts

Active ingredient

Lidocaine HCl   0.5%


Purpose

Topical Analgesic


Uses

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas.


When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens or if symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away


Directions

Inactive ingredients

Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.


Principal Display Panel

WESTERN FAMILY

Aloe Vera

MOISTURIZING GEL

Sunburn Pain Relief

with Lidocaine HCL

clean, fresh fragrance soothes and moisturizes


NET WT. 8 OZ. (226 g)

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WESTERN FAMILY ALOE VERA MOISTURIZING 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MENTHOL (UNII: L7T10EIP3A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-012-16226 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/02/2014
Labeler - WESTERN FAMILY FOODS, INC. (192166072)

Revised: 7/2014
Document Id: b0650448-ef6f-4cc1-9771-8d3eaead739b
Set id: 6d3c13ae-23d3-4c30-b58e-3aece2125bd0
Version: 1
Effective Time: 20140702
 
WESTERN FAMILY FOODS, INC.