ALLANTOIN- advanced derma spray aerosol, spray 
Premier Brands of America 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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Advanced Derma Spray

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

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)

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Generic_Advanced Derma Spray_50-126XX-01.jpg

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)

Revised: 3/2018
Document Id: 6fcf6d76-6171-46f1-90d3-be413b1d9a8d
Set id: 63b67264-9ba6-4d27-a325-146872ae3d47
Version: 1
Effective Time: 20180327
 
Premier Brands of America Inc.