Yuma: Package Insert and Label Information

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

Principal Display Panel – Yuma Backwoods Survivor Carton
(click image for full-size original)
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

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