26630421-08fb-b209-e063-6394a90a3d1c

SPL v1

SPL

SPL Set ID 26630421-08fb-b209-e063-6394a90a3d1c

Route

topical

Published

Effective Date 2024-11-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

allantoin (0.5 g)

Inactive Ingredients

glycerin gold butylene glycol xanthan gum fructose paeonia lactiflora root tocopherol

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-08-23

Description

Fructose Glycerin Butylene Glycol Corn Glutenin Amino Acids Cereus Grandiflorus (Cactus) Flower Extract Paeonia Albiflora Root Extract Tocopherol Xanthan Gum Gold

Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Allantoin

Indications and Usage

Once or twice per week, gently massage scrub into damp skin using circular motions. Leave it on for few minutes and then rinse thoroughly with warm water.

Dosage and Administration

Once or twice per week, gently massage scrub into damp skin using circular motions. Leave it on for few minutes and then rinse thoroughly with warm water.

Description

Fructose Glycerin Butylene Glycol Corn Glutenin Amino Acids Cereus Grandiflorus (Cactus) Flower Extract Paeonia Albiflora Root Extract Tocopherol Xanthan Gum Gold

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Fructose

Glycerin

Butylene Glycol

Corn Glutenin Amino Acids

Cereus Grandiflorus (Cactus) Flower Extract

Paeonia Albiflora Root Extract

Tocopherol

Xanthan Gum

Gold

Section 51945-4

Section 55105-1

Exfoliation.

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Allantoin

Indications and Usage (34067-9)

Once or twice per week, gently massage scrub into damp skin using circular motions. Leave it on for few minutes and then rinse thoroughly with warm water.

Dosage and Administration (34068-7)

Once or twice per week, gently massage scrub into damp skin using circular motions. Leave it on for few minutes and then rinse thoroughly with warm water.

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Fructose

Glycerin

Butylene Glycol

Corn Glutenin Amino Acids

Cereus Grandiflorus (Cactus) Flower Extract

Paeonia Albiflora Root Extract

Tocopherol

Xanthan Gum

Gold

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Exfoliation.

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GOLD", "unii": "79Y1949PYO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FRUCTOSE", "unii": "6YSS42VSEV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PAEONIA LACTIFLORA ROOT", "unii": "3Z3866YW6P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Once or twice per week, gently massage scrub into damp skin using circular motions. Leave it on for few minutes and then rinse thoroughly with warm water.", "34068-7": "Once or twice per week, gently massage scrub into damp skin using circular motions. Leave it on for few minutes and then rinse thoroughly with warm water.", "34071-1": "For external use only.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs.", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin.", "51727-6": "Fructose Glycerin Butylene Glycol Corn Glutenin Amino Acids Cereus Grandiflorus (Cactus) Flower Extract Paeonia Albiflora Root Extract Tocopherol Xanthan Gum Gold", "55105-1": "Exfoliation.", "55106-9": "Allantoin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:19.171593 · Updated: 2026-03-14T23:04:56.462927