MAXIMUM STRENGTH BURN RELIEF ALOE GEL SCHERER LABS- lidocaine hydrochloride 4.00% gel 
Product Quest Mfg.

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 ingredients                            Purpose

Lidocaine Hydrochloride - 4.00%      Topical analgesic

Uses

For the temporary relief of pain and itching
due to • sunburn • minor burns • insect bites
• minor cuts • scrapes • minor skin irritation

Warnings
For external use only.
When using this product • avoid contact with
eyes. Rinse with water if contact occurs.
Stop use and ask doctor if • if symptoms persist
for more than 7 days.
Do not use in large quantities, particularly over raw
surfaces or blistered areas.

Keep out of the reach of children

Directions

• Adults and children 2 years and
older: apply to affected area not more than 3-4 times
a day. • Children under 2 years
of age: consult a physician.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Avena
Sativa (Oat) Kernel Extract, Blue
1, Caprylyl Glycol, Chlorphenesin,
Dimethyl Isosorbide, Glycerin,
Hydroxyethylcellulose, Isopropyl
Alcohol, Phenoxyethanol,
Polysorbate 20, Propanediol,
Tocopheryl Acetate, Water.

image description

MAXIMUM STRENGTH BURN RELIEF ALOE GEL  SCHERER LABS
lidocaine hydrochloride 4.00% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-5002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OAT (UNII: Z6J799EAJK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Chlorphenesin (UNII: I670DAL4SZ)  
Dimethyl Isosorbide (UNII: SA6A6V432S)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Alcohol (UNII: ND2M416302)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Propanediol (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-5002-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/08/2016
Labeler - Product Quest Mfg. (927768135)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(64048-5002) , label(64048-5002)

Revised: 5/2018
Document Id: 25953ec6-bd39-4693-b246-8ba17156ae21
Set id: 54425e59-f0f7-41fb-ab0b-f449d5688baf
Version: 1
Effective Time: 20180529
 
Product Quest Mfg.