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 
Meijer Distribution

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

Questions 1-888-593-0593
DIST BY MEIJER DISTRIBUTION, INC
GRAND RAPIDS, MI 49544
www. meijer.com

Principal display panel

meijer

Sunburn Relief Aloe Vera Gel Pain Relieving Gel With Lidocaine

Compare to Solarcaine*

NET WT 8 OZ (226 g)

image description

0053001/005AB

ALOE VERA GEL 
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41250-093
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: 41250-093-34226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/29/2016
Labeler - Meijer Distribution (006959555)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(41250-093)

Revised: 11/2017
 
Meijer Distribution


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