65d4acc8-6936-3fd3-e053-2991aa0ab3d3

SPL v2

SPL

SPL Set ID 65d4acc8-6936-3fd3-e053-2991aa0ab3d3

Route

topical

Published

Effective Date 2018-02-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (10 mg) zinc cation (1 mg)

Inactive Ingredients

water propylparaben methylparaben decyl oleate sodium cetostearyl sulfate trolamine propylene glycol cetostearyl alcohol edetic acid stearic acid .alpha.-tocopherol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph not final active Since 2018-02-21

Description

Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%

Medication Information

Warnings

For external use only.

Uses

temporarily relieves pain and itching associated with:

insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak, and poison sumac
dries the oozing and weeping of poison ivy, poison oak and poison sumac

Directions

do not use more 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

Other Information

protect from excessive heat (40°C/104°F)

Inactive Ingredients

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

Description

Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%

Section 50565-1

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

Section 50567-7

When using this product avoid contact with eyes

Section 51945-4

Net weight 20 g

NDC#70648-133-01

Section 55105-1

Topical analgesic

skin protectant

Questions

www.ohiolabpharma.us

Do Not Use

on large areas of the body
with any other product containing diphenhydramine, even one taken by mouth

Active Ingredients

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

Ask A Doctor Before Use

on chicken pox
on measles

Stop Use and Ask A Doctor If

condition worsens or does not improve within 7 days
symptoms persist for more than 7 days or clear up and occur again within a few days

Structured Label Content

Warnings (warnings)

For external use only.

Uses

temporarily relieves pain and itching associated with:

insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak, and poison sumac
dries the oozing and weeping of poison ivy, poison oak and poison sumac

Directions

do not use more 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

Other Information (Other information)

protect from excessive heat (40°C/104°F)

Inactive Ingredients (inactive ingredients)

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

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 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 51945-4 (51945-4)

Net weight 20 g

NDC#70648-133-01

Section 55105-1 (55105-1)

Topical analgesic

skin protectant

Questions

www.ohiolabpharma.us

Do Not Use (do not use)

on large areas of the body
with any other product containing diphenhydramine, even one taken by mouth

Active Ingredients (ACTIVE INGREDIENTS)

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

Ask A Doctor Before Use (Ask a doctor before use)

on chicken pox
on measles

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or does not improve within 7 days
symptoms persist for more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DECYL OLEATE", "unii": "ZGR06DO97T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CETOSTEARYL SULFATE", "unii": "7ZBS06BH4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak and poison sumac", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product avoid contact with eyes", "51945-4": "Net weight 20 g NDC#70648-133-01", "55105-1": "Topical analgesic skin protectant", "warnings": "For external use only.", "Questions": "www.ohiolabpharma.us", "Directions": "do not use more 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", "do not use": "on large areas of the body with any other product containing diphenhydramine, even one taken by mouth", "Other information": "protect from excessive heat (40°C/104°F)", "ACTIVE INGREDIENTS": "Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%", "inactive ingredients": "cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E", "Ask a doctor before use": "on chicken pox on measles", "Stop use and ask a doctor if": "condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:41.021713 · Updated: 2026-03-14T22:55:19.604592