Sunburn Relief Aloe Vera Gel

Sunburn Relief Aloe Vera Gel

Drug Labeling and Warnings

Drug Details

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ALOE VERA GEL- lidocaine hcl gel 
Valu Merchandisers, CO.

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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Sunburn Relief Aloe Vera Gel

Active ingredient

Lidocaine HCl 0.5%

Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations

Warnings

For external use only

When using this product

avoid contact with the eyes

Do not use

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or 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

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Inactive ingredients

water, propylene glycol, glycerin Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, diazolidinyl urea, menthol, disodium EDTA, blue 1, yellow 5

*This product is not manufactured or distributed by Bayer, distributor of Solarcaine Cool Aloe Burn Relief Formula

Proudly distributed by: Valu Merchandisers, Co. 

5000 Kansas Ave, Kansas City, KS 66106

Best Choice 100% Guaranteed

www.bestchoicebrand.com

Best Choice

Principal display panel

Best Choice

Sunburn Relief Gel with Aloe

Pain Relieving Gel With Lidocaine HCL

Compare to Solarcaine*

NET WT 8 OZ (226 g)

image description

005.001/005AB

ALOE VERA GEL 
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63941-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
MENTHOL (UNII: L7T10EIP3A)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63941-005-34226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/14/2017
Labeler - Valu Merchandisers, CO. (868703513)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(63941-005)

Revised: 12/2018
 
Valu Merchandisers, CO.


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