Hydrolatum - DailyMed Details

Hydrolatum

SPL v4

SPL

SPL Set ID 9ef53da4-8f1f-46b0-e053-2995a90aa7a6

Route

TOPICAL

Published

Effective Date 2022-09-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (45 g)

Inactive Ingredients

Water Sorbitan Sesquioleate Methylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-02-19

Description

White Petrolatum, 54%

Medication Information

Warnings and Precautions

for external use only
Keep out of reach of children
Stop using if allergic

Indications and Usage

temporarily protects and helps relieve chapped or cracked skin
helps prevent and protect from the drying effects of wind and cold weather

Dosage and Administration

apply as needed

Description

White Petrolatum, 54%

Section 50565-1

Keep out of reach of children

Section 50566-9

if condition lasts more than 7 days

Section 50567-7

do not get into eyes
do not get into mouth

Section 50570-1

deep or punctured wounds
animal bites
serious burns

Section 51727-6

Methylparaben, Purified Water, Sorbitan Sesquioleate

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

White Petrolatum, 54%

Section 60561-8

Store at 20-25C (68-77F)

Section 69762-3

Call Toll Free at 1-800-601-3843 or email [email protected]

Structured Label Content

Indications and Usage (34067-9)

temporarily protects and helps relieve chapped or cracked skin
helps prevent and protect from the drying effects of wind and cold weather

Dosage and Administration (34068-7)

apply as needed

Warnings and Precautions (34071-1)

for external use only
Keep out of reach of children
Stop using if allergic

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

if condition lasts more than 7 days

Section 50567-7 (50567-7)

do not get into eyes
do not get into mouth

Section 50570-1 (50570-1)

deep or punctured wounds
animal bites
serious burns

Section 51727-6 (51727-6)

Methylparaben, Purified Water, Sorbitan Sesquioleate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

White Petrolatum, 54%

Section 60561-8 (60561-8)

Store at 20-25C (68-77F)

Section 69762-3 (69762-3)

Call Toll Free at 1-800-601-3843 or email [email protected]

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN SESQUIOLEATE", "unii": "0W8RRI5W5A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "45", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "temporarily protects and helps relieve chapped or cracked skin helps prevent and protect from the drying effects of wind and cold weather", "34068-7": "apply as needed", "34071-1": "for external use only Keep out of reach of children Stop using if allergic", "50565-1": "Keep out of reach of children", "50566-9": "if condition lasts more than 7 days", "50567-7": "do not get into eyes do not get into mouth", "50570-1": "deep or punctured wounds animal bites serious burns", "51727-6": "Methylparaben, Purified Water, Sorbitan Sesquioleate", "55105-1": "Skin Protectant", "55106-9": "White Petrolatum, 54%", "60561-8": "Store at 20-25C (68-77F)", "69762-3": "Call Toll Free at 1-800-601-3843 or email complaints@dpharm.net"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:23.589599 · Updated: 2026-03-14T23:01:22.645369