FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS- lidocaine hydrochloride spray
Fruit Of The Earth, Inc.

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.

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Fruit of the Earth Cool Blue Aloe Mist Continuous Spray

Active Ingredients

Lidocaine (1.0%)

Purpose

External Analgesic

Uses

For the temporary relief of sunburn, minor burns, scrapes, insect bites, minor rashes, minor skin irritations and windburned skin.

Warnings

EXTERNAL USE ONLY
Do not use near heat, flame or while smoking. Avoid long term storage above 104°F (40°C).
Do not spray directly in eyes or face.
May stain some fabrics.

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

Do not use on puncture wounds

When using this product

Keep out of eyes and eyelids. If contact with eyes occurs, 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, or if symptoms persist more than 7 days or 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.

Directions

Adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
Spray on hands to apply to face.
Use in a well-ventilated area.
Children under 2 years of age, ask a doctor.

Inactive Ingredients

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

Fruit of the Earth

Cool Blue Aloe Mist

Continuous Spray

177 mL

NDC: 62217-201-20

Label

FRUIT OF THE EARTH COOL BLUE ALOE MIST CONTINUOUS
lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62217-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOCETETH-20 (UNII: O020065R7Z)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62217-201-20	177 mL in 1 CANISTER; Type 0: Not a Combination Product	09/12/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/12/2014	09/12/2014

Labeler - Fruit Of The Earth, Inc. (079559467)

Name	Address	ID/FEI	Business Operations
Establishment
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-201)

Revised: 1/2022

Document Id: d4cba05a-399b-5e08-e053-2995a90afc14

Set id: aa39c75e-5efb-435b-95ab-a41cfc36e4f2

Version: 3

Effective Time: 20220104

Fruit Of The Earth, Inc.