ALRA THERAPY- allantoin lotion 
NEUE COSMETIC COMPANY 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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ACTIVE INGREDIENTS

ALLANTOIN 0.5%

PURPOSE

SKIN PROTECTANT

USES

HELPS PREVENT AND RELIEVE SKIN IRRITATION, REDNESS AND PAIN, SUCH AS SYMPTOMS CAUSED BY RADIATION THERAPY OR DERMATOLOGICAL PROCEDURES.

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

DO NOT USE ON

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

APPLY A SMALL AMOUNT OF ALRA THERAPY LOTION TO THE AFFECTED AREA TWICE DAILY OR AS DIRECTED BY PHYSICIAN.

INACTIVE INGREDIENTS

100% ALOE VERA (NO WATER), LANOLIN OIL, ACETYLATED LANOLIN, ISOPROPYL LANOLATE, GLYCEROL STEARATE, PEG-100 STEARATE, SOLUBLE COLLAGEN, STEARIC ACID, CETYL ALCOHOL, STEARYL ALCOHOL, TOCOPHERYL ACETATE, METHYLPROPANEDIOL, TETRASODIUM EDTA, CAPRYLYL GLYCOL, POTASSIUM SORBATE, PHENYLPROPANOL, TRIETHANOLAMINE

QUESTIONS OR COMMENTS?

CALL 1-877-265-9092

WWW.ALRA.COM

Therapy Lotion with Drug Box 20150810

ALRA THERAPY 
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58894-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LANOLIN OIL (UNII: OVV5IIJ58F)  
ACETYLATED LANOLIN (UNII: 2X654GD19H)  
ISOPROPYL LINOLEATE (UNII: 4MW1E9AT4H)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58894-101-11100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/14/2016
Labeler - NEUE COSMETIC COMPANY INC (012392107)

Revised: 6/2016
Document Id: 7b2c3b0c-073f-4199-982f-aff7e709dc7e
Set id: 9e5d736d-0f07-416c-aca1-636b0fd0a04f
Version: 1
Effective Time: 20160614
 
NEUE COSMETIC COMPANY INC