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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Premier Brands 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

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)

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56104-034-85	85 g in 1 CAN; Type 0: Not a Combination Product	03/27/2018	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/27/2018	12/31/2021

Labeler - Premier Brands of America Inc. (117557458)

Revised: 1/2023

Document Id: f31f5a5b-8961-c1b4-e053-2995a90a817d

Set id: 63b67264-9ba6-4d27-a325-146872ae3d47

Version: 5

Effective Time: 20230125

Premier Brands of America Inc.