BODY- menthol powder
DZA Brands 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.

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Healthy Accents 379.001/379AB

Active ingredient

Menthol 0.15%

Purpose

External analgesic

Uses

for temporary relief of pain and itching due to:

minor burns
sunburn
minor cuts
scraps
insect bites
minor skin irritation
rash due to poison ivy, poison oak, poison sumac

warnings

For external use only

When using this product

avoid contact with the 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

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

disclaimers

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

Distributed by: DZA Brands, LLC

Salisbury, NC 28147

Scarborough, ME 04074

For product questions or concerns

Please include UPC number and code from package.

379.001/379AB

Principal display panel

Healthy Accents

medicated

body powder

external analgesic

cooling
absorbent
itch relieving

Compare to the active ingredient of Gold Bond Medicated Body Powder

NET WT 10 OZ (283 g)

image description

BODY
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-001
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:55316-001-38	283 g in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2013	04/21/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/14/2013	04/21/2021

Labeler - DZA Brands LLC (090322194)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
MK Packaging		047022405	manufacture(55316-001)

Revised: 4/2021

Document Id: 8439dfee-b3d8-46f0-9770-2ccc3e61f7a9

Set id: 93a609dc-5378-401b-9846-f0b90b604a4c

Version: 6

Effective Time: 20210421

DZA Brands LLC