BODY- menthol powder
Supervalu

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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Equaline 379.001 379AB

Active ingredient

Menthol 0.15%

Purpose

External analgesic

Uses

for temporary relief of pan and itching due to:

mnor 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

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 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

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

Questions

Call 1-877-932-7948

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 Reaction

DISTRIBUTED BY SUPERVALU INC

EDEN PRAIRIE, MN 55344 USA

We're committed to your satisfaction and guarantee the quality of this product.

Please have package available.

379.001/379AB

principal display panel

EQUALINE

Compare to Gold Bond Medicated Body Powder

MEDICATED

BODY POWDER

External Analgesic

Relieves pain & itch

Absorbs moisture

NET WT 10 oz (283g)

image description

BODY
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-003
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:41163-003-38	283 g in 1 BOTTLE; Type 0: Not a Combination Product	09/27/2013	04/16/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/27/2013	04/16/2021

Labeler - Supervalu (006961411)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
MK Packaging		047022405	manufacture(41163-003)

Revised: 4/2021

Document Id: a2cfdbc9-0ddf-4cae-8200-65e90c6ed199

Set id: a66b402a-2b89-46e0-8de0-5fda0b9ab3e4

Version: 7

Effective Time: 20210416

Supervalu