61010-8300, Itch Relief Spray

61010-8300, Itch Relief Spray
SPL v3
SPL
SPL Set ID 4f4c801b-d894-4fa3-b024-6ca41a5f2a95
Route
TOPICAL
Published
Effective Date 2013-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20.3 g)
Inactive Ingredients
Diazolidinyl Urea Edetate Disodium Glycerin C12-15 Pareth-9 Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-02
Description

Drug Facts

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Drug Facts

Uses:

For the temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, poison oak and poison sumac.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of childrenIf swallowed, get medical help or contact a poison control center right away.

Warnings

For external use only

Do Not Use
  • on large areas of the body
  • with any other products using diphenhydramine hydrochloride, even one taken by mouth
Directions:
  • 12 and over: apply to affected area not more than 3 to 4 times daily
  • under 12: consult a doctor
Active Ingredients

Diphenhydramine hydrochloride 2%

Inactive Ingredients:

Germaben II, edetate disodium, glycerin, tomadol 25-9, purified water, triethanolamine

Ask A Doctor Before Use
  • on chicken pox
  • on measles
Principal Display Panel

NDC 61010-8300-1

Safetec

Diphenhydramine

Itch Relief Spray

Relief from pain and

itching due to insect

bites and rashes from

poison ivy, poison oak

and poison sumac.

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077

www.safetec.com

2 fl. oz. (59.1ml) Reorder no. 57001

When Using This Product
  • avoid contact with the eyes
Stop Use and Ask Doctor If
  • condition worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses:

For the temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, poison oak and poison sumac.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of childrenIf swallowed, get medical help or contact a poison control center right away.

Purpose

External Analgesic

Warnings

For external use only

Do Not Use (Do not use)
  • on large areas of the body
  • with any other products using diphenhydramine hydrochloride, even one taken by mouth
Directions:
  • 12 and over: apply to affected area not more than 3 to 4 times daily
  • under 12: consult a doctor
Active Ingredients

Diphenhydramine hydrochloride 2%

Inactive Ingredients:

Germaben II, edetate disodium, glycerin, tomadol 25-9, purified water, triethanolamine

Ask A Doctor Before Use (Ask a doctor before use)
  • on chicken pox
  • on measles
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 61010-8300-1

Safetec

Diphenhydramine

Itch Relief Spray

Relief from pain and

itching due to insect

bites and rashes from

poison ivy, poison oak

and poison sumac.

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077

www.safetec.com

2 fl. oz. (59.1ml) Reorder no. 57001

When Using This Product (When using this product)
  • avoid contact with the eyes
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • condition worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.038339 · Updated: 2026-03-14T23:02:30.868416