cc738c6e-b0a2-2e94-e053-2995a90abd65

SPL v1

SPL

SPL Set ID cc738c6e-b0a2-2e94-e053-2995a90abd65

Route

topical

Published

Effective Date 2021-09-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

aluminum zirconium tetrachlorohydrex gly (0.2 g)

Inactive Ingredients

peg-8 dilaurate activated charcoal aluminum starch octenylsuccinate silicon dioxide aloe vera leaf menthyl lactate, (-)- cyclomethicone 5 stearyl alcohol hydrogenated castor oil menthol hamamelis virginiana leaf alpha-tocopherol acetate

Identifiers & Packaging

Pill Appearance

Color: gray

Marketing Status

otc monograph final active Since 2021-09-20

Medication Information

Warnings and Precautions

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Structured Label Content

Warnings and Precautions (34071-1)

Active Ingredient (55106-9)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

[{"name": "PEG-8 DILAURATE", "unii": "FC11NGP7E6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACTIVATED CHARCOAL", "unii": "2P3VWU3H10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM STARCH OCTENYLSUCCINATE", "unii": "I9PJ0O6294", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHYL LACTATE, (-)-", "unii": "2BF9E65L7I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY", "unii": "8O386558JE", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CYCLOMETHICONE 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED CASTOR OIL", "unii": "ZF94AP8MEY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HAMAMELIS VIRGINIANA LEAF", "unii": "T07U1161SV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:44.949517 · Updated: 2026-03-14T22:59:48.053698