eb651769-4d98-2b3b-e053-2a95a90a36b0

SPL v2

SPL

SPL Set ID eb651769-4d98-2b3b-e053-2a95a90a36b0

Route

topical

Published

Effective Date 2023-02-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

sorbitol (0.00675 g) saccharomyces lysate (0.0525 g) water (0.00075 g) 1,2-hexanediol (1.219341 mL) glycerin (0.0165 g) leuconostoc/radish root ferment filtrate (0.16875 g) hyaluronic acid (0.000015 g) fd&c blue no. 1 (0.00003 g) phenoxyethanol (0.0075 g) aloe vera leaf (0.000009 g) ethylhexylglycerin (0.0141 g)

Inactive Ingredients

caesalpinia spinosa resin sodium benzoate edetate disodium anhydrous potassium sorbate

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2022-10-19 Until 2027-01-14

Medication Information

Warnings and Precautions

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50570-1

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 50570-1 (50570-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

[{"name": "CAESALPINIA SPINOSA RESIN", "unii": "WL3883U2PO", "classCode": "IACT", "strengthNumerator": "0.00675", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "ACTIB", "strengthNumerator": "0.0525", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SACCHAROMYCES LYSATE", "unii": "R85W246Z1C", "classCode": "ACTIB", "strengthNumerator": "0.00075", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "1.219341", "strengthDenominator": "1.5", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "ACTIB", "strengthNumerator": "0.0165", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.16875", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE", "unii": "D2QHA03458", "classCode": "ACTIB", "strengthNumerator": "0.000015", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "0.00003", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYALURONIC ACID", "unii": "S270N0TRQY", "classCode": "ACTIB", "strengthNumerator": "0.0075", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "ACTIB", "strengthNumerator": "0.000009", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "0.0141", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "ACTIB", "strengthNumerator": "0.008955", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "0.003", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "ACTIB", "strengthNumerator": "0.0015", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "0.0003", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:13.298384 · Updated: 2026-03-14T23:01:17.657881