Fruit Of The Earth Cool Blue Aloe Mist Continuous Spray

Fruit Of The Earth Cool Blue Aloe Mist Continuous Spray
SPL v2
SPL
SPL Set ID d4caae4c-efba-2453-e053-2995a90a5e5f
Route
TOPICAL
Published
Effective Date 2018-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Isoceteth-20 Trolamine Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Sodium Methylchloroisothiazolinone/methylisothiazolinone Mixture Sulisobenzone Fd&c Blue No. 1 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-09-12

Description

Lidocaine 1% (as Lidocaine HCl)

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 1% (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 51945-4

Warnings

For External Use Only

Directions
  • Adults and children 2 years of age and older; spray onto affected area not more than 3 to 4 times daily. Hold container 4 to 6 inches away from face from affected area to apply
  • Children under 2 years of age: ask a doctor.
  • To apply to the face, spray into hand and apply.
​do Not Use

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

Other Information

May stain some fabrics.

Active Ingredients

Lidocaine 1% (as Lidocaine HCl)

Inactive Ingredients

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

When Using This Product
  • Avoid sprying in eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure.
  • do not store at temperatures above 120°F.
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children

If swallowed, seek medical help or contact a Poison Control Center immediately.


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 51945-4 (51945-4)

Purpose

Topical Analgesic

Warnings

For External Use Only

Directions
  • Adults and children 2 years of age and older; spray onto affected area not more than 3 to 4 times daily. Hold container 4 to 6 inches away from face from affected area to apply
  • Children under 2 years of age: ask a doctor.
  • To apply to the face, spray into hand and apply.
​do Not Use (​Do not use)

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

Other Information (Other information)

May stain some fabrics.

Active Ingredients

Lidocaine 1% (as Lidocaine HCl)

Inactive Ingredients

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

When Using This Product (When using this product)
  • Avoid sprying in eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure.
  • do not store at temperatures above 120°F.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, seek medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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