ALCOHOLADA GEL PAIN RELIEVING PAIN- lidocaine hydrochloride gel 
Aruba Aloe Balm NV

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Alcoholada Gel Pain Relieving Pain

Drug Facts

Active ingredient

Lidocaine Hydrochloride 0.5%

Purpose

Pain Relieving Gel

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or minor skin irritations.

Warnings

For external use only.

Do not use 

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

When using this product 

avoid contact with the eyes.

Stop use and ask a doctor if

conditions worsens, or if symptoms persist for more than 7 days or clears up nand 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 under2 years of age: Consult a doctor.

Other Information

  • Store in a cool dry place
  • Protect from heat and light

Inactive ingredients

Water (Aqua/Eau), Alcohol Denat. Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Sodium Hydroxide, FD&C #1 (C.I. 42090), Fragrance (Parfum)

Package Labeling:

Label7

ALCOHOLADA GEL PAIN RELIEVING PAIN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-173
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53675-173-0065 mL in 1 TUBE; Type 0: Not a Combination Product10/25/201702/29/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/25/201702/29/2024
Labeler - Aruba Aloe Balm NV (855442273)
Establishment
NameAddressID/FEIBusiness Operations
Aruba Aloe Balm NV855442273manufacture(53675-173)

Revised: 3/2024
Document Id: 129aa744-910f-a181-e063-6394a90a276b
Set id: b8c662dd-4af0-426b-b521-0a821868c888
Version: 3
Effective Time: 20240301
 
Aruba Aloe Balm NV