eb01a962-ab38-18ec-e053-2995a90acdeb

SPL v2

SPL

SPL Set ID eb01a962-ab38-18ec-e053-2995a90acdeb

Route

topical

Published

Effective Date 2022-10-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fragrance 13576 (0.15 g) grape seed oil (0.00726 g) glyceryl monostearate (0.25 g) linalool, (+/-)- (3.5 g) phenoxyethanol (0.0114 g) propylene glycol (0.45 g) titanium dioxide (1.5 g) palmitic acid (1 g) butylated hydroxytoluene (5.5 g) starch, rice (4.752 mL) alcohol (0.00639 g) c12-20 acid peg-8 ester (4 g) trolamine (0.0115 g) isomethyl-.alpha.-ionone (0.05 g) hydroxyacetophenone (0.012 g) perlite (25.04945 g) glycerin (0.75 g) ethylhexylglycerin .beta.-citronellol, (r)- water stearic acid cetearyl ethylhexanoate

Inactive Ingredients

limonene, (+)-

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2022-10-14 Until 2027-10-13

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

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Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:13.297157 · Updated: 2026-03-14T23:01:17.657881