ALLANTOIN- advanced derma spray aerosol, spray

Allantoin by

Drug Labeling and Warnings

Allantoin by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only.

Contents under pressure. Do not puncture or incinerate. Do not store above 120 °F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

• on deep or puncture wounds
• on animal bites
• on serious burns

When using this product

• avoid spraying in eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

• shake well before using
• apply as needed
• spray product onto affected area(s) and massage into skin in a circular motion
• for scars on face or near eyes spray product into palm of hand and apply with fingertips

Other information

store at room temperature

Inactive ingredients

Water, Dimethyl Ether, Isostearyl Isostearate, Isopropyl Isostearate, PPG-3 Benzyl Ether Myristate, Pentaerythrityl Tetracaprylate/Caprate, Methylsilanol Hydroxyproline Aspartate, Glycerin, Butylene Glycol, Allium Cepa (Onion) Bulb Extract, Sucrose Palmitate, Glyceryl Stearate, Glyceryl Stearate Citrate, Sucrose, Mannan, Xanthan Gum, Cetyl Hydroxyethylcellulose, Rutin, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Phaseolus Lunatus (Green Bean) SEed Extract, Phenoxyethanol, Fragrance, Potassium Sorbate, Salicylic Acid

Questions?

Call 1-866-964-0939

Principal Display Panel

Premier

Advanced Derma Spray

Allantoin 0.5% - Skin Protectant

Improves overall appearance of SCARS*

Improves the appearance of texture & smoothness on STRETCH MARKS*

Dermatologist tested

Paraben Free

Shake well before use.

Net WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

ALLANTOIN 
advanced derma spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.425 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHYL ETHER (UNII: AM13FS69BX)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE (UNII: 832C4KF14X)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ONION (UNII: 492225Q21H)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
SUCROSE (UNII: C151H8M554)
YEAST MANNAN (UNII: 91R887N59P)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
RUTIN (UNII: 5G06TVY3R7)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
LIMA BEAN (UNII: 112YH1ZMX2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SALICYLIC ACID (UNII: O414PZ4LPZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-034-85	85 g in 1 CAN; Type 0: Not a Combination Product	03/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/27/2018

Labeler - Premier Brands of America Inc. (080051232)