PERCARA ORIGINAL MEDICATED POWDER- menthol, zinc oxide powder
Willard Manufacturing 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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PerCara Original Medicated Powder

Active ingredient: Purpose

Menthol 0.1%..................................Anti-Itch

Zinc oxide 1.0%..............................Skin Protectant

USE for the temporary relief of pain and itching due to:

- minor cuts - sun burn - insect bites - poison ivy - poison oak
- poison sumac - scrapes - minor burns - minor skin irritations
Dries the oozing and weeping of:
- poison ivy - poison oak - poison sumac

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

When using this product avoid contact with eyes

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Warnings For external use only

Directions

- adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily

- children under 2 years of age: do not use, consult a doctor

- For best results dry skin thoroughly before applying

Inactive ingredients talc, salicylic acid, boric acid, zinc stearate, thymol, eucalyptol

image of label

PERCARA ORIGINAL MEDICATED POWDER
menthol, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67933-0003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BORIC ACID (UNII: R57ZHV85D4)
ZINC STEARATE (UNII: H92E6QA4FV)
THYMOL (UNII: 3J50XA376E)
EUCALYPTOL (UNII: RV6J6604TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67933-0003-1	283 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/22/2012	12/20/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/22/2012	12/20/2017

Labeler - Willard Manufacturing Inc. (208799143)

Name	Address	ID/FEI	Business Operations
Establishment
Willard Manufacturing Inc.		208799143	manufacture(67933-0003)

Revised: 12/2017

Document Id: 60c7d173-4857-d50b-e053-2a91aa0a446e

Set id: 92d0798e-1cf7-4fbf-a5c6-3ad1c9531821

Version: 2

Effective Time: 20171220

Willard Manufacturing Inc.