Hydrophor Ointment

SPL v7

SPL

SPL Set ID e6099df7-d418-479a-9d2e-ced523585aed

Route

TOPICAL

Published

Effective Date 2023-03-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (42 g)

Inactive Ingredients

Ceresin Lanolin Mineral Oil Paraffin Phenoxyethanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Active Ingredient: Petrolatum 42% Purpose: Skin protectant

Medication Information

Indications and Usage

When using this product:

do not get into eyes

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

deep or puncture wounds
animals bites
serious burns

Description

Active Ingredient: Petrolatum 42% Purpose: Skin protectant

Uses

temporarily protects minor:

cuts
scrapes
burns

temporarily protects and helps relieve

chapped or cracked skin and lips
helps protects from the drying effects of wind and cold weather

Section 44425-7

Other Information

do not use if inner seal is broken or missing

Learn more at www.HydrophorUS.com

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Section 53413-1

Questions?

Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

Manufactured in U.S.A

Warnings

For External Use Only.

Directions

Apply as needed.

Drug Facts

Active Ingredient:

Petrolatum 42%

Purpose:

Skin protectant

Inactive Ingredient

Ceresin Wax, Lanolin, Mineral Oil, Paraffin Wax & Phenoxyethanol.

Structured Label Content

Uses

temporarily protects minor:

cuts
scrapes
burns

temporarily protects and helps relieve

chapped or cracked skin and lips
helps protects from the drying effects of wind and cold weather

Indications and Usage (34067-9)

When using this product:

do not get into eyes

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

deep or puncture wounds
animals bites
serious burns

Section 44425-7 (44425-7)

Other Information

do not use if inner seal is broken or missing

Learn more at www.HydrophorUS.com

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

Manufactured in U.S.A

Warnings

For External Use Only.

Directions

Apply as needed.

Drug Facts

Active Ingredient:

Petrolatum 42%

Purpose:

Skin protectant

Inactive Ingredient

Ceresin Wax, Lanolin, Mineral Oil, Paraffin Wax & Phenoxyethanol.

Advanced Ingredient Data

[{"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "42", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily protects minor: cuts scrapes burns temporarily protects and helps relieve chapped or cracked skin and lips helps protects from the drying effects of wind and cold weather", "34067-9": "When using this product: do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Do not use on deep or puncture wounds animals bites serious burns", "44425-7": "Other Information do not use if inner seal is broken or missing Learn more at www.HydrophorUS.com", "50565-1": "KEEP OUT OF REACH OF CHILDREN.", "53413-1": "Questions? Please Call 1(877) 225-6999 Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 Manufactured in U.S.A", "Warnings": "For External Use Only.", "Directions": "Apply as needed.", "Drug Facts": "Active Ingredient: Petrolatum 42% Purpose: Skin protectant", "Inactive Ingredient": "Ceresin Wax, Lanolin, Mineral Oil, Paraffin Wax & Phenoxyethanol."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:21.274752 · Updated: 2026-03-14T23:12:34.529887