4613 - DailyMed Details

4613

SPL v14

SPL

SPL Set ID 46df52c8-0cbf-213e-e054-00144ff88e88

Route

TOPICAL

Published

Effective Date 2017-01-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Lanolin (50 g)

Inactive Ingredients

Disodium Edta-copper Lanolin Alcohols Dmdm Hydantoin Sodium Borate Sorbitan Sesquioleate Water Yellow Wax Mineral Oil Aloe

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-01-05

Description

Lanolin 50%

Medication Information

Warnings and Precautions

For external use only

When using this product, do not get into eyes

Stop use and ask doctor if condition lasts more than 7 days

Do not use on deep or punture wounds, animal bites, serious burns

Indications and Usage

Temporarily protects minor cuts, scrapes and burns

Temporarily protects and helps relieve chafed, chapped or cracked skin and lips

Helps prevent incontinence -associated dermatitis

Dosage and Administration

Gently cleanse and dry area. Apply as needed to affected area.

Description

Lanolin 50%

Section 50565-1

Keep out of the reach of children

If swallowed get medical help or contact a poison control center right away

Section 51727-6

Inactive Ingredient:

Aloe Barbadensis Leaf Juice

Beeswax (Yellow Wax)

Disodium EDTA

DMDM Hydantoin

Lanolin Alcohol

Mineral Oil

Petrolatum

Sodium Borate

Sorbitan Sesquioleate

Water

Section 51945-4

NDC-68599-6202-1

McKesson

Skin Protectant Cream with Lanolin

Net Weight

0.18 oz (5 g)

144 per Box

MFR# 4613

Section 55105-1

Purpose: Skin protectant

Section 55106-9

Lanolin 50%

Principal Display Panel

NDC-68599-6202-1

McKesson

Skin Protectant Cream with Lanolin

Net Weight

0.18 oz (5 g)

MFR# 4613

Structured Label Content

Indications and Usage (34067-9)

Temporarily protects minor cuts, scrapes and burns

Temporarily protects and helps relieve chafed, chapped or cracked skin and lips

Helps prevent incontinence -associated dermatitis

Dosage and Administration (34068-7)

Gently cleanse and dry area. Apply as needed to affected area.

Warnings and Precautions (34071-1)

For external use only

When using this product, do not get into eyes

Stop use and ask doctor if condition lasts more than 7 days

Do not use on deep or punture wounds, animal bites, serious burns

Section 50565-1 (50565-1)

Keep out of the reach of children

If swallowed get medical help or contact a poison control center right away

Section 51727-6 (51727-6)

Inactive Ingredient:

Aloe Barbadensis Leaf Juice

Beeswax (Yellow Wax)

Disodium EDTA

DMDM Hydantoin

Lanolin Alcohol

Mineral Oil

Petrolatum

Sodium Borate

Sorbitan Sesquioleate

Water

Section 51945-4 (51945-4)

NDC-68599-6202-1

McKesson

Skin Protectant Cream with Lanolin

Net Weight

0.18 oz (5 g)

144 per Box

MFR# 4613

Section 55105-1 (55105-1)

Purpose: Skin protectant

Section 55106-9 (55106-9)

Lanolin 50%

Principal Display Panel (Principal display Panel)

NDC-68599-6202-1

McKesson

Skin Protectant Cream with Lanolin

Net Weight

0.18 oz (5 g)

MFR# 4613

Advanced Ingredient Data

[{"name": "DISODIUM EDTA-COPPER", "unii": "6V475AX06U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN ALCOHOLS", "unii": "884C3FA9HE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN SESQUIOLEATE", "unii": "0W8RRI5W5A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE", "unii": "V5VD430YW9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Temporarily protects minor cuts, scrapes and burns Temporarily protects and helps relieve chafed, chapped or cracked skin and lips Helps prevent incontinence -associated dermatitis", "34068-7": "Gently cleanse and dry area. Apply as needed to affected area.", "34071-1": "For external use only When using this product, do not get into eyes Stop use and ask doctor if condition lasts more than 7 days Do not use on deep or punture wounds, animal bites, serious burns", "50565-1": "Keep out of the reach of children If swallowed get medical help or contact a poison control center right away", "51727-6": "Inactive Ingredient: Aloe Barbadensis Leaf Juice Beeswax (Yellow Wax) Disodium EDTA DMDM Hydantoin Lanolin Alcohol Mineral Oil Petrolatum Sodium Borate Sorbitan Sesquioleate Water", "51945-4": "NDC-68599-6202-1 McKesson Skin Protectant Cream with Lanolin Net Weight 0.18 oz (5 g) 144 per Box MFR# 4613", "55105-1": "Purpose: Skin protectant", "55106-9": "Lanolin 50%", "Principal display Panel": "NDC-68599-6202-1 McKesson Skin Protectant Cream with Lanolin Net Weight 0.18 oz (5 g) MFR# 4613"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:47.680190 · Updated: 2026-03-14T23:04:04.169402