ALCOHOLADA PAIN RELIEVING- lidocaine hydrochloride gel 
Aruba Aloe Balm NV

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Alcoholada Gel Pain Relieving Gel

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 quantities, 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 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: Consult a doctor.

Other Information

• Store in a cool dry place

• Protect from hear and light

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Vera (Aloe Barbadensis) Gel, Caprylyl Glycol, Chlorphenesin, FD&C Blue No.1, Fragrance (Parfum), Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water (Aqua).

Package Labeling:

Label

ALCOHOLADA PAIN RELIEVING 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-164
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53675-164-00251 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/201702/29/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/10/201702/29/2024
Labeler - Aruba Aloe Balm NV (855442273)

Revised: 3/2024
Document Id: 129ace05-0f21-a8e8-e063-6394a90ae420
Set id: 7ec2a1b2-d59b-43df-85cb-0e84817fe156
Version: 4
Effective Time: 20240301
 
Aruba Aloe Balm NV