BODY- menthol powder
Foodhold U.S.A. 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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Care One 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 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 sold by weight, not by volume. Some settling may occur during handling and shipping

Adverse reactions

DISTRIBUTED BY

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-848-9949

2013 Ahold Licensing, Sarl

Quality guaranteed or your money back.

379.001/379AB

principal display panel

Care One

MEDICATED

BODY

POWDER

External Aalgesic

Cooling

Absorbent

Itch Relief

NET WT 10 OZ (283 g)

image description

BODY
menthol powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-379
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:41520-379-38	283 g in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2012	04/13/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/10/2012	04/13/2022

Labeler - Foodhold U.S.A. LLC (809183973)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
MK Packaging		047022405	manufacture(41520-379)

Revised: 4/2022

Document Id: f1f80d3d-d2ad-4703-8d4a-343ee75fbf91

Set id: a5b3aa73-ec62-459f-990f-ddccf9ddddfc

Version: 8

Effective Time: 20220413

Foodhold U.S.A. LLC