ARUBA ALOE ALCOHOLADA- lidocaine hydrochloride cream

Aruba Aloe Alcoholada by

Drug Labeling and Warnings

Aruba Aloe Alcoholada by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 heat and light

Inactive Ingredients

Water (Aqua/Eau), Alcohol Denat., Polysorbate 20, Fragrance (Parfum), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Glyceryl Laurate, Glyceryl Undecylenate, 8.5 fl oz (251 mL) Aminomethyl Propanol, FD&C Blue #1 (C.I. 42090).

Package Labeling:

INGREDIENTS AND APPEARANCE

ARUBA ALOE ALCOHOLADA 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL LAURATE (UNII: Y98611C087)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-212-00	251 mL in 1 TUBE; Type 0: Not a Combination Product	06/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/15/2025

Labeler - Aruba Aloe Balm NV (855442273)

Registrant - Aruba Aloe Balm NV (855442273)