Yuma by Yuma Outdoors LLC / Vanguard Soap LLC YUMA- oatmeal soap

Yuma by

Drug Labeling and Warnings

Yuma by is a Otc medication manufactured, distributed, or labeled by Yuma Outdoors LLC, Vanguard Soap LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Colloidal Oatmeal (avena sativa) 1%

Purpose

Skin Protectant

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions apply as needed

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – Yuma Backwoods Survivor Carton

INGREDIENTS AND APPEARANCE

YUMA 
oatmeal soap

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.205 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75933-1425-1	1 in 1 CARTON

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	Business Operations
Vanguard Soap LLC		831404954	MANUFACTURE