POISON IVY/OAK- kaolin, zinc oxide spray
Rosemont Ventures, 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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Poison Ivy/Oak Spray 2 oz

Active Ingredients

Kaolin 4.0%

Zinc Oxide 1.0%

Purpose

Kaolin 4.0%........................Drying Agent

Zinc Oxide 1.0%.......................Skin Protectant

Uses

Dries the oozing and weeping of poison

ivy
oak
sumac

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

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

Directions

Shake well and apply as needed

Inactive Ingredients

Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Extract, Aqua (Water), Avena Sativa (Colloidal Oatmeal) Kernel Flour, Azadirachta Indica (Neem) Seed Oil, Bisabolol, Butyrospermum Parkii (Shea) Butter†, Calcium Gluconate, Caprylic/Capric Triglyceride, Citric Acid, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Gluconolactone, Glycerin, Glyceryl Stearate SE, Melaleuca Alternifolia (Tea Tree) Leaf Oil†, Potassium Sorbate, Sodium Benzoate, Squalane, Stearyl Alcohol, Xanthan Gum, Zea Mays (Corn) Starch

Questions or Comments?

Call (800) 246-7328 or visit www.allterrainco.com

Effective, natural & safe

ALL TERRAIN

Poison Ivy/Oak Spray

Kaolin & Zinc Oxide Skin Protectant

Dries oozing & weeping of pioson ivy, oak & sumac

Made with 95+% naturally derived ingredients

2.0 FL. OZ. (59 mL)

POISON IVY/OAK
kaolin, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82960-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO)	KAOLIN	4 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLUCONOLACTONE (UNII: WQ29KQ9POT)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
STARCH, CORN (UNII: O8232NY3SJ)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
LEVOMENOL (UNII: 24WE03BX2T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
SQUALANE (UNII: GW89575KF9)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
OATMEAL (UNII: 8PI54V663Y)
SHEA BUTTER (UNII: K49155WL9Y)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82960-020-01	1 in 1 CARTON	09/15/2022
1		59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	09/15/2022

Labeler - Rosemont Ventures, Inc. (933509465)

Name	Address	ID/FEI	Business Operations
Establishment
Monarch PCM, LLC		080000294	manufacture(82960-020)

Revised: 9/2022

Document Id: e931d589-ade6-7910-e053-2a95a90a2023

Set id: e931d589-ade5-7910-e053-2a95a90a2023

Version: 1

Effective Time: 20220921

Rosemont Ventures, Inc.