MedPath

Itch Relief

Carring Mill Itch Relief Pump Spray

Approved
Approval ID

3cd1933c-6341-50d6-e063-6294a90aca32

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 19, 2025

Manufacturers
FDA

FSA Store Inc.

DUNS: 049283340

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diphenhydramine HCl and Zinc Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code81522-726
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl and Zinc Acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 19, 2025
FDA Product Classification

INGREDIENTS (8)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CAMPHOR (NATURAL)Inactive
Code: N20HL7Q941
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
PVPInactive
Code: FZ989GH94E
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/12/2017

​Principal Display Panel

caring mill

Extra Strength

Itch Relief

Pump Spray

Diphenhydramine Hydrochloride 2%/

External Analgesic

Easy-To-Spray Pump

  • Relieves pain and itching associated

with minor burns, cuts, scrapes,

insect bites, and skin irritations

  • Helps cool & soothe skin
  • Ozone-Friendly, Non-Aerosol

2.5 FL. OZ. (74 mL)

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/10/2013

​Uses

for the temporary relief of pain and itching associated with:

  • minor burns
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/12/2017

Active ingredients

Diphenhydramine HCl 2.0%,

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/10/2013

​Purpose

External analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/14/2025

Warnings

For external use only.

Flammable:

Keep away from fire or flame.

​Do not use

  • on large areas of the body
  • on chicken pox, poison ivy, or sunburn
  • on broken, blistered, or oozing skin
  • more often than directed
  • with any other product containing diphenhydramine, even one taken by mouth

​When using this product

  • avoid contact with the eyes

​Stop use and ask doctor if

  • conditions worsens
  • 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/10/2013

​Directions

  • adults and children 2 years of age and older: spray on affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult a doctor.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/10/2013

​Other information

  • store between 20° to 25°C (68° to 77°F)
  • shake well before use
  • pump must be primed before use

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/10/2013

​Inactive ingredients

SD ALCOHOL 40-B, WATER, GLYCERIN, CAMPHOR, TROMETHAMINE, PVP, ALOE BARBADENSIS LEAF JUICE

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/10/2013

​Questions?

1-866-964-0939

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 8/19/2025

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Itch Relief - FDA Drug Approval Details