AL0040600 ALBA COOLING ALOE BURN RELIEF- menthol, allantoin spray

AL0040600 Alba Cooling Aloe Burn Relief by

Drug Labeling and Warnings

AL0040600 Alba Cooling Aloe Burn Relief by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc, The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Allantoin 0.5%

Menthol 0.5%

PURPOSE

Mentol - Topical Analgetic

Allantoin - Skin Protectant

INDICATIONS & USAGE

• Provides cooling pain relieve
• Skin protection and first aid for the temporary relief of pain and itching associated with sunburn, minor burns, minor skin irritations, insect bites, minor cuts and scrapes

WARNINGS

For external use only. Avoid contact with eyes, mouth and mucous membranes. Do not use on deep puncture wounds, animal bites or serious burns. Do not puncture or incinerate. Contents under preassure .Do not store at temperature above 120°. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if condition worsens, lasts more than 7days or clears up and occurs again in within a few days or if skin rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

DOSAGE & ADMINISTRATION

Adults and children 2 years old and older: apply to affected area up to 4 times daily or as directed by doctor. Hold 4-6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Sprayon hand and apply to face.Use in well-ventiled area. Children under 2 years of age : ask a doctor.

INACTIVE INGREDIENT

Aquq (Water),Glycerin, Caprylyl/Capric Glucoside, Aloe Barbadensis Leaf Juice, Cananga Odarata Flower Oil, Mentha Piperita (Peppermint) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Caprylic/Capric Trigluceride, Citric Acid, Terpineol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Hexyl Cinnamal, Hydroxycitronellol, Limonene, Linalool.

QUESTIONS

Questions?Visit www.albabotanica.com or call 888-659-7730

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AL0040600 ALBA COOLING ALOE BURN RELIEF 
menthol, allantoin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2406
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANANGA OIL (UNII: 8YOY78GNNX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
APPLE (UNII: B423VGH5S9)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CUCUMBER (UNII: YY7C30VXJT)
TERPINEOL (UNII: R53Q4ZWC99)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDROXYCITRONELLOL (UNII: R0B4U2I48W)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2406-6	177 g in 1 CAN; Type 0: Not a Combination Product	01/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/13/2016

Labeler - The Hain Celestial Group, Inc (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc		117115556	manufacture(61995-2406)