OTC Medication Information: Yuma

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.

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

YUMA oatmeal soap

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75933-1425 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (OATMEAL) OATMEAL 1.205 g

Inactive Ingredients Ingredient Name Strength ALOE ROSEMARY MENTHA ARVENSIS FLOWER OIL ALLANTOIN CAMELLIA SINENSIS ROOT WEST INDIAN LEMONGRASS OIL POTASSIUM ALUM EUCALYPTUS OIL PEPPERMINT OIL ZINC RICINOLEATE D&C YELLOW NO. 10 D&C GREEN NO. 5 SODIUM COCOATE SODIUM PALM KERNELATE WATER GLYCERIN PENTASODIUM PENTETATE KAOLIN COCOA BUTTER SODIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:75933-1425-1 1 SOAP (BAR) in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2011

Labeler — Yuma Outdoors LLC (965948461)

Establishment
Name	Address	ID/FEI	Operations
Vanguard Soap LLC		831404954	MANUFACTURE

Revised: 01/2011 Yuma Outdoors LLC