AL0040600 ALBA COOLING ALOE BURN RELIEF- menthol, allantoin spray 
The Hain Celestial Group, 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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Alba Botanica Cooling Aloe Burn Relief Spray

Allantoin 0.5%

Menthol 0.5%

Mentol - Topical Analgetic

Allantoin - Skin Protectant

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. If swallowed get medical help or contact Poison Center right away.

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.

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

cane label

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)

Revised: 10/2019
Document Id: 9491f22f-5d8b-77d9-e053-2995a90a9a1e
Set id: 29a52bdc-ff3b-5cca-e054-00144ff88e88
Version: 2
Effective Time: 20191010
 
The Hain Celestial Group, Inc