OTC Medication Information: Aloe Vera Gel

ALOE VERA GEL- lidocaine hydrochloride and menthol gel
Retail Business Services, LLC

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.

Active ingredient

Lidocaine HCl 0.7%

Menthol 0.2%

Purpose

Topical analgesic

Uses

for the temporary relief of pain and itching associated with

• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• 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

condition worsens, or if symptoms persist for more than 7 days or clear 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: ask a doctor

Inactive ingredients

water, alcohol denat., polysorbate 20, glycerin, Aloe barbadensis leaf juice, carbomer, benzophenone-4, triethanolamine, benzyl alcohol, phenoxyethanol, blue 1

DISTRIBUTED BY:

AUDSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

DSP-TN-21091

DSP-MO-20087

principal display panel

CAREONE

AFTER SUN

Gel with Aloe

Pain Relieving Gel

• with Lidocaine and Menthol
• Soothing

NET 16 FL OZ (473 mL)

ALOE VERA GEL lidocaine hcl, menthol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-747 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 7 mg in 1 mL MENTHOL (MENTHOL) MENTHOL 2 mg in 1 mL

Inactive Ingredients Ingredient Name Strength water ALCOHOL POLYSORBATE 20 glycerin ALOE VERA LEAF CARBOXYPOLYMETHYLENE SULISOBENZONE TROLAMINE BENZYL ALCOHOL phenoxyethanol FD&C BLUE NO. 1

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72476-747-43 473 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/24/2021

Labeler — Retail Business Services, LLC (967989935)

Registrant — Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, LLC		790752542	manufacture (72476-747)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon, LLC		088520668	manufacture (72476-747)

Revised: 01/2023 Retail Business Services, LLC