Fruit Of The Earth Aloe Vera Cool Blue Gel

Fruit Of The Earth Aloe Vera Cool Blue Gel
SPL v4
SPL
SPL Set ID 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79
Route
TOPICAL
Published
Effective Date 2017-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (10 mg)
Inactive Ingredients
Aloe Vera Leaf Isoceteth-20 Trolamine Carbomer Homopolymer Type C Edetate Sodium Fd&c Blue No. 1 Methylchloroisothiazolinone Methylisothiazolinone Sulisobenzone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-09-10
Description

Lidocaine 1.0% (as Lidocaine HCl)

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Lidocaine 1.0% (as Lidocaine HCl)

Uses

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

Section 50565-1

Keep out of reach of children.If swallowed, seek medical help or contact a Poison Control Center immediately.

Section 50567-7

When using this productavoid contact with eyes. If contact occurs, rinse with water to remove.

Section 50569-3

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50570-1

​Do not use​in large quantities, particularly over raw surfaces or blistered areas

Section 51945-4

Fruit of the Earth

Aloe Vera

Cool Blue Gel

567 grams

NDC: 62217-200-20

Section 60561-8

Other Information: May stain some fabrics.

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:Ask a doctor.
Active Ingredients

Lidocaine 1.0% (as Lidocaine HCl)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Isoceteth-20, Triethanolamine, Carbomer, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Blue 1.

Structured Label Content

Uses

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

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, seek medical help or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

When using this productavoid contact with eyes. If contact occurs, rinse with water to remove.

Section 50569-3 (50569-3)

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50570-1 (50570-1)

​Do not use​in large quantities, particularly over raw surfaces or blistered areas

Section 51945-4 (51945-4)

Fruit of the Earth

Aloe Vera

Cool Blue Gel

567 grams

NDC: 62217-200-20

Section 60561-8 (60561-8)

Other Information: May stain some fabrics.

Purpose

External Analgesic

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:Ask a doctor.
Active Ingredients

Lidocaine 1.0% (as Lidocaine HCl)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Isoceteth-20, Triethanolamine, Carbomer, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Blue 1.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:19.721083 · Updated: 2026-03-14T23:03:21.577672