BODY- menthol, zinc oxide powder
McKesson

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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Sunmark 379.001-379AB

Active ingredient

Menthol 0.15%

Purpose

External analgesic

Uses

for temporary relief of pan and itching due to:

minor cuts
sunburn
insect bites
poison ivy
poison oak
poison sumac
scrapes
minor burns
minor skin irritations

warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor

condition worsens, or if symtpoms persist for 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

adults and children 2 year 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

Zea mays (corn) starch, sodium bicarbonate, tricalcium phosphate, zinc oxide, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

Claims

This product is not manufactured or distributed by Chattem, distributor of Gold Bond Medicated Body Powder

This product is sold by weight, not by volume. Some settling may occur during handling and shipping.

Adverse reactions

Another Quality Product

Distributed By McKesson

One Post Street

San Francisco, CA 94104

Money Back Guarantee

Please visit us at

www.sunmarkbrand.com

principal display panel

sunmark

Compare to Gold Bond

medicated

body

powder

External Analgesic

Cooling

Absorbent

ITCH RELIEVING

NET WT. 10 OZ (283 G)

image description

BODY
menthol, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-801
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
ZINC OXIDE (UNII: SOI2LOH54Z)
GUM TALHA (UNII: H18F76G097)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-801-92	283 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2013	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/01/2013	04/28/2021

Labeler - McKesson (116956644)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
MK Packaging		047022405	manufacture(49348-801)

Revised: 4/2021

Document Id: 0eb90aef-0023-44bd-9110-b985cf40e50d

Set id: 99b6e2c0-1684-4ccb-8669-1656735c08a2

Version: 10

Effective Time: 20210428

McKesson