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

Fruit of the Earth Cool Blue Aloe Mist Continuous by

Drug Labeling and Warnings

Fruit of the Earth Cool Blue Aloe Mist Continuous by is a Otc medication manufactured, distributed, or labeled by Fruit Of The Earth, Inc., Fruit Of The Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

​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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

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