Aruba Aloe Alcoholada Gel

Aruba Aloe Alcoholada Gel
SPL v2
SPL
SPL Set ID f56c62b0-75db-4499-858e-54e10b0e140a
Route
TOPICAL
Published
Effective Date 2025-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Alcohol Polysorbate 20 Aloe Vera Leaf Caprylyl Glycol Glyceryl Laurate Aminomethylpropanol Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-15

Description

Lidocaine Hydrochloride 0.5%

Purpose

Pain Relieving Gel


Medication Information

Purpose

Pain Relieving Gel

Description

Lidocaine Hydrochloride 0.5%

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.

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.
Do Not Use

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

Drug Facts

Active Ingredient

Lidocaine Hydrochloride 0.5%

Other Information
  • Store in a cool dry place
  • Protect from heat and light
Package Labeling:

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).

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.


Structured Label Content

Uses

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

Purpose

Pain Relieving Gel

Warnings

For external use only.

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.
Do Not Use (Do not use)

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

Drug Facts

Active Ingredient (Active ingredient)

Lidocaine Hydrochloride 0.5%

Other Information
  • Store in a cool dry place
  • Protect from heat and light
Package Labeling:

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).

When Using This Product (When using this product)

avoid contact with the eyes.

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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