Amerfresh Medicated

Manufacturer: Amercare Products Inc
Effective date: 2011-05-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:28:14

Label at a glance#

ProductAmerfresh Medicated

Active ingredientMenthol, Zinc Oxide

Label structure8 sections

Indications and uses

temporarily relieves the pain and itch associated with: Minor cuts Sunburn Insect Bites Scrapes Prickly Heat Minor Burns Rashes Minor Skin Irritations Dries the oozing of poison ivy, oak and sumac.

Dosage and administration

adults and children 2 years and older apply freely up to 3 or 4 times daily Children under 2 years ask a doctor For best results dry skin thoroughly before applying

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients	Purpose
Menthol 0.15%	Anti-itch
Zinc Oxide 1.0%	Skin Protection

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the pain and itch associated with:

Minor cuts
Sunburn
Insect Bites
Scrapes
Prickly Heat
Minor Burns
Rashes
Minor Skin Irritations
Dries the oozing of poison ivy, oak and sumac.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms do not get better within 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and older	apply freely up to 3 or 4 times daily
Children under 2 years	ask a doctor
For best results dry skin thoroughly before applying

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Talc, Eucalyptol, Methyl salicylate, Salicylic acid, Thymol, Zinc stearate.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
AMERCARE PRODUCTS, INC

PRINCIPAL DISPLAY PANEL - 283g Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMERFRESH^®

BONDED
*FOR*
PURITY

MEDICATED

BODY

POWDER

NET WT.10 OZ. (283g)

PRINCIPAL DISPLAY PANEL - 283g Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
577232	menthol 0.15 % / zinc oxide 1 % Topical Powder	PSN	1
577232	menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical Powder	SCD	1
577232	Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical Powder	SY	1
577232	menthol 0.15 % / zinc oxide 1 % Topical Powder	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51460-0504-1	2019-10-29	C162847	48780-1	960f7f55-d24a-8e05-e053-dbdaa90a074a	AMERFRESH ® MEDICATED BODY POWDER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51460-0504-1	Amerfresh Medicated	283 g in 1 CONTAINER	POWDER	283		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51460-0504	AMERFRESH MEDICATED (MENTHOL AND ZINC OXIDE) POWDER [AMERCARE PRODUCTS INC]	1	Legacy NDC, 1 package rows	20110609_fded3bee-45e8-47e1-8292-b15983654788.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	1
Eucalyptol	INACTIVE INGREDIENT	RV6J6604TK	1
Methyl Salicylate	INACTIVE INGREDIENT	LAV5U5022Y	1
Salicylic Acid	INACTIVE INGREDIENT	O414PZ4LPZ	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
Thymol	INACTIVE INGREDIENT	3J50XA376E	1
Zinc Stearate	INACTIVE INGREDIENT	H92E6QA4FV	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Amerfresh Medicated
Menthol and Zinc Oxide
Menthol
Zinc Oxide
Talc
Salicylic Acid
Methyl Salicylate
Eucalyptol
Thymol
Zinc Stearate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51460-0504	51460-0504-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Menthol	L7T10EIP3A	ACTIB
Zinc Oxide	SOI2LOH54Z	ACTIB
Talc	7SEV7J4R1U	IACT
Salicylic Acid	O414PZ4LPZ	IACT
Methyl Salicylate	LAV5U5022Y	IACT
Eucalyptol	RV6J6604TK	IACT
Thymol	3J50XA376E	IACT
Zinc Stearate	H92E6QA4FV	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 64 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Talc	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	SOLUTION / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 7 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	PASTE, DENTIFRICE / DENTAL	2.4 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	POWDER / TOPICAL	0.1 mg/mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	TABLET, FILM COATED / ORAL	15.2 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	POWDER / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	TABLET, COATED / ORAL	1.82 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	DOUCHE / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	JELLY / NASAL	68.5 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	CREAM / TOPICAL	6 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	DROPS / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 7 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	CAPSULE / ORAL	2.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	TABLET / BUCCAL	2.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	TABLET, EXTENDED RELEASE / ORAL	36 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	TABLET / ORAL		72 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	LOZENGE / ORAL		53 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	CAPSULE / ORAL	16 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	TABLET / ORAL	10 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	DROPS / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	LIQUID / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	PASTE, DENTIFRICE / DENTAL	1.1 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
Zinc Stearate	ZINC STEARATE	H92E6QA4FV	SYRUP / ORAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
01111ea5-3692-4b9a-889f-6619fb056913			fded3bee-45e8-47e1-8292-b15983654788	2011-05-12	Warnings	Exact identifier spl id: 01111ea5-3692-4b9a-889f-6619fb056913 spl set id: fded3bee-45e8-47e1-8292-b15983654788

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.