Biocorneum Hc Advanced Scar Supervision Anti-itch Gel

SPL v2

SPL

SPL Set ID cae7655c-6595-4639-ab94-2f96575ce6cf

Route

TOPICAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrocortisone (1 g)

Inactive Ingredients

Cyclomethicone 5 Dimethicone Dimethyl Isosorbide Pentylene Glycol Propylene Glycol Silicon Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-05-10

Description

Hydrocortisone acetate 1%

Purpose

Anti-itch

Medication Information

Purpose

Anti-itch

Description

Hydrocortisone acetate 1%

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, soaps, detergents and cosmetics.

Warnings

For external use only

Directions

ensure that affected area is clean and dry
apply evenly in a very thin layer to affected area not more than 3 to 4 times daily
children under 2 years of age : consult a doctor

Do Not Use

in or near the eyes
for the treatment of diaper rash: ask a doctor

Active Ingredient

Hydrocortisone acetate 1%

Other Information

store below 25 degree (77 degree F)

Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethyl Isosorbide, Pentylene Glycol, Propylene Glycol, Silicon Dioxide

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Manufactured in the Usa For: Enaltus Suwanee, Ga 30024 Usa 2012 Enaltus

Biocorneum Hc Advanced Scar Supervision Anti Itch Gel 5g (43474 000 05)

Structured Label Content

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, soaps, detergents and cosmetics.

Purpose

Anti-itch

Warnings

For external use only

Directions

ensure that affected area is clean and dry
apply evenly in a very thin layer to affected area not more than 3 to 4 times daily
children under 2 years of age : consult a doctor

Do Not Use (Do not use)

in or near the eyes
for the treatment of diaper rash: ask a doctor

Active Ingredient (Active ingredient)

Hydrocortisone acetate 1%

Other Information (Other information)

store below 25 degree (77 degree F)

Inactive Ingredients (Inactive ingredients)

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethyl Isosorbide, Pentylene Glycol, Propylene Glycol, Silicon Dioxide

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

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately.

Manufactured in the Usa For: Enaltus Suwanee, Ga 30024 Usa 2012 Enaltus (Manufactured in the USA for: enaltus Suwanee, GA 30024 USA 2012 enaltus)

Biocorneum Hc Advanced Scar Supervision Anti Itch Gel 5g (43474 000 05) (bioCorneum HC Advanced Scar Supervision Anti-Itch Gel 5g (43474-000-05))

Advanced Ingredient Data

[{"name": "HYDROCORTISONE", "unii": "WI4X0X7BPJ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CYCLOMETHICONE 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHYL ISOSORBIDE", "unii": "SA6A6V432S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PENTYLENE GLYCOL", "unii": "50C1307PZG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, soaps, detergents and cosmetics.", "Purpose": "Anti-itch", "Warnings": "For external use only", "Directions": "ensure that affected area is clean and dry apply evenly in a very thin layer to affected area not more than 3 to 4 times daily children under 2 years of age : consult a doctor", "Do not use": "in or near the eyes for the treatment of diaper rash: ask a doctor", "Active ingredient": "Hydrocortisone acetate 1%", "Other information": "store below 25 degree (77 degree F)", "Inactive ingredients": "Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethyl Isosorbide, Pentylene Glycol, Propylene Glycol, Silicon Dioxide", "Stop use and ask a doctor if": "condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:27.839572 · Updated: 2026-03-14T22:53:06.901698