AMERFRESH MEDICATED BODY POWDER- menthol and zinc oxide powder

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient                                        Purpose

Menthol  0.15%                                       Anti - Itch

Zinc Oxide  1.0%                                      Skin Protectant

PURPOSE

Uses

Temporarily relieves the pain itch associated with:
Minor cuts
Sunburns
Insect bites
Scrapes
Minor burns
Minor skin irritation

Warnings

For external use only
Do not use
Broken skin
Deep or puncture wounds
Serious burns

When using this product

• avoid contact with the eyes
• Keep away from face and mouth to avoid breathing powder.

Stop use and ask a doctor:
If the condition worsens
Symptoms persist for more than 7 days or clear up and occur again within a few days.
Redness, irritation, swelling, or pain persists or increases.

Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Directions

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

Other information

• This products is sold by weight, not by volumes
• Settings will occur during handling & shipping

Inactive ingredients

Acacia Seyal Gum, Eucalyptol, Methyl Salicylate, salicylic Acid, Sodium Bicarbonate, Thymol, Tri-calcium Phosphate, Zea Mays (Corn) starch, Zinc Stearate.

Product label

INGREDIENTS AND APPEARANCE

AMERFRESH MEDICATED BODY POWDER 
menthol and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87510-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
STARCH, CORN (UNII: O8232NY3SJ)
ZINC STEARATE (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87510-001-01	285 g in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/25/2026

Labeler - ONEST LIMITED (772058774)

Establishment
Name	Address	ID/FEI	Business Operations
ONEST LIMITED		772058774	manufacture(87510-001)