YUMA- oatmeal soap 
Yuma Outdoors LLC

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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Drug Facts

Active Ingredients

Colloidal Oatmeal (avena sativa) 1%

Purpose

Skin Protectant

Uses • temporarily protects and helps relieve minor skin irritation and itching due to •poison ivy, oak or sumac •insect bites •rashes

Warnings For external use only

When using this product •do not get into 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

•do not use on •deep or puncture wounds •animal bites

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions •apply as needed

Inactive Ingredients Vegetable soap base (sodium palmate, sodium cocoate and/or sodium palm kemelate, water, glycerin, pentasodium pentetate), kaolin clay (kaolin), cocoa butter (theobroma cacao), sodium chloride, aloe vera leaf (aloe barbadensis), rosemary oil (rosmarinus officinalis), menthol (mentha arvensis), allantoin (ureidohydantoin), green tea (camelia sinensis), lemongrass (cymbopogon citratus), ammonium alum, eucalyptus oil (eucalyptus globulus), peppermint oil (mentha piperita), zinc ricinoleate, FD&C Yellow No. 10, FD&C Green No. 5.

Package Label - Principal Display Panel – Yuma Backwoods Survivor Carton

Principal Display Panel – Yuma Backwoods Survivor Carton

YUMA 
oatmeal soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75933-1425
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.205 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
ROSEMARY (UNII: IJ67X351P9)  
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
ALLANTOIN (UNII: 344S277G0Z)  
CAMELLIA SINENSIS ROOT (UNII: 8H54O0V2K3)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
POTASSIUM ALUM (UNII: 1L24V9R23S)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ZINC RICINOLEATE (UNII: BOH1Z111J2)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
SODIUM COCOATE (UNII: R1TQH25F4I)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
KAOLIN (UNII: 24H4NWX5CO)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75933-1425-11 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2011
Labeler - Yuma Outdoors LLC (965948461)
Establishment
NameAddressID/FEIBusiness Operations
Vanguard Soap LLC831404954MANUFACTURE

Revised: 1/2011
Document Id: 506650c0-1839-11e0-8305-0002a5d5c51b
Set id: 423532a0-1839-11e0-af81-0002a5d5c51b
Version: 1
Effective Time: 20110105
 
Yuma Outdoors LLC