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

Purpose

External Analgesic

Description

Lidocaine 1.0% (as Lidocaine HCl)


Medication Information

Warnings
  • For External Use Only
Uses

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

Purpose

External Analgesic

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

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

Description

Lidocaine 1.0% (as Lidocaine HCl)

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.

Active Ingredients

Lidocaine 1.0% (as Lidocaine HCl)


Structured Label Content

Warnings
  • For External Use Only
Uses

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

Purpose

External Analgesic

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

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

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.

Active Ingredients

Lidocaine 1.0% (as Lidocaine HCl)


Advanced Ingredient Data


Raw Label Data

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