SPL v2
SPL
SPL Set ID f047af5d-45d8-11ae-e053-2a95a90a2a22
Route
TOPICAL
Published
Effective Date 2023-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg)
Inactive Ingredients
Menthol, Unspecified Form Polysorbate 20 Edetate Disodium Benzethonium Chloride Water Zinc Acetate Hypromellose 2208 (100 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-16

Description

Diphenhydramine HCL 2%


Medication Information

Warnings and Precautions

Do not use:

  • on large areas of the body
  • with any other product containing diphenhydramine, even on taken by mouth
Indications and Usage

for the temporary relief of pain and itching associated with:

•minor burns•sunburn•minor cuts•scrapes•insect bites

•minor skin irritaitons

•rashes due to poison ivy, poison oak and poison sumac

Dosage and Administration

Directions

  • do not use more than directed
  • adults and children 2 years of age and older:
    • cleanse skin with soap and warm water and dry affected area
    • apply to affected area not more than 3 times daily
    • may be covered with a bandage; if bandage let dry first
    • children under 2 years of age: do not use, consult a doctor
Description

Diphenhydramine HCL 2%

Section 44425-7

Other information

Store at 59 to 86°F (15 to 30°C)

Section 50565-1

Keep out of reach of children.

  • if swallowed, get medical help or contact a poison control center right away
Section 50566-9

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product:

  • avoid contact with eyes
Section 50569-3

Ask a doctor before use:

  • on chicken pox
  • on measles
Section 51727-6

benzethonium chloride, disodium EDTA, fragrance, hypromellose, menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

Section 51945-4

Section 53413-1

Questions?

Call 1-800-482-4464

Serious side effects may be reported to this number

Section 55105-1

Purpose Topical analgesic/antihistamine

Section 55106-9

Diphenhydramine HCL 2%


Structured Label Content

Indications and Usage (34067-9)

for the temporary relief of pain and itching associated with:

•minor burns•sunburn•minor cuts•scrapes•insect bites

•minor skin irritaitons

•rashes due to poison ivy, poison oak and poison sumac

Dosage and Administration (34068-7)

Directions

  • do not use more than directed
  • adults and children 2 years of age and older:
    • cleanse skin with soap and warm water and dry affected area
    • apply to affected area not more than 3 times daily
    • may be covered with a bandage; if bandage let dry first
    • children under 2 years of age: do not use, consult a doctor
Warnings and Precautions (34071-1)

Do not use:

  • on large areas of the body
  • with any other product containing diphenhydramine, even on taken by mouth
Section 44425-7 (44425-7)

Other information

Store at 59 to 86°F (15 to 30°C)

Section 50565-1 (50565-1)

Keep out of reach of children.

  • if swallowed, get medical help or contact a poison control center right away
Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product:

  • avoid contact with eyes
Section 50569-3 (50569-3)

Ask a doctor before use:

  • on chicken pox
  • on measles
Section 51727-6 (51727-6)

benzethonium chloride, disodium EDTA, fragrance, hypromellose, menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

Call 1-800-482-4464

Serious side effects may be reported to this number

Section 55105-1 (55105-1)

Purpose Topical analgesic/antihistamine

Section 55106-9 (55106-9)

Diphenhydramine HCL 2%


Advanced Ingredient Data


Raw Label Data

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