Private Label Itch Relief Gel

SPL v2

SPL

SPL Set ID e42f484d-a641-3489-e053-2a95a90a4254

Route

TOPICAL

Published

Effective Date 2018-12-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (2 mg)

Inactive Ingredients

Anhydrous Citric Acid Camphor (synthetic) Hypromellose, Unspecified Alcohol Methylparaben Propylparaben Propylene Glycol Diazolidinyl Urea Sodium Citrate Water Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-12-20

Description

Do not use more often than directed. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac.

Dosage and Administration

Do not use more often than directed.

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: ask a doctor.

Description

Do not use more often than directed. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Section 50565-1

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

Section 51727-6

Camphor, Citric Acid, Diazolidnyl Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

Section 55105-1

External Analgesic

Section 55106-9

Diphenhydramine HCl 2%

Equate Label

[

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac.

Dosage and Administration (34068-7)

Do not use more often than directed.

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

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 51727-6 (51727-6)

Camphor, Citric Acid, Diazolidnyl Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

Section 55105-1 (55105-1)

External Analgesic

Section 55106-9 (55106-9)

Diphenhydramine HCl 2%

Equate Label

[

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac.", "34068-7": "Do not use more often than directed. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.", "34071-1": "For external use only.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Camphor, Citric Acid, Diazolidnyl Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.", "55105-1": "External Analgesic", "55106-9": "Diphenhydramine HCl 2%", "Equate Label": "["}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:35.336144 · Updated: 2026-03-14T23:02:13.859151