SPL v2
SPL
SPL Set ID 26556b9b-1c3a-6cf5-e063-6394a90ab26c
Routes
TOPICAL RECTAL
Published
Effective Date 2024-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (0.5 g)
Inactive Ingredients
Benzalkonium Chloride Glycerin Sodium Citrate Water Anhydrous Citric Acid Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-07

Description

Witch Hazel 50%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporary relief of anal itching & burning

Dosage and Administration

Gently apply to affected areas by patting and then discard

Description

PRE-MOISTENED WITCH HAZEL TOWELETTE

Section 50565-1

Keep out of reach of children

Section 50566-9

Stop use and ask doctor if rectal bleeding or continued irritation occurs

Section 50569-3

Stop use and ask doctor if rectal bleeding or continued irritation occurs

Section 51727-6

Benzalkonium Chloride, Citric Acid, Glycerin, Methylparaben, Purified Water, Sodium Citrate

Section 55105-1

Astringent

Section 55106-9

Witch Hazel 50%

Section 59845-8

Gently apply to affected areas by patting and then discard

Aer Traveler Packet Artwork


Structured Label Content

Indications and Usage (34067-9)

Temporary relief of anal itching & burning

Dosage and Administration (34068-7)

Gently apply to affected areas by patting and then discard

Warnings and Precautions (34071-1)

For external use only

Description (34089-3)

PRE-MOISTENED WITCH HAZEL TOWELETTE

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask doctor if rectal bleeding or continued irritation occurs

Section 50569-3 (50569-3)

Stop use and ask doctor if rectal bleeding or continued irritation occurs

Section 51727-6 (51727-6)

Benzalkonium Chloride, Citric Acid, Glycerin, Methylparaben, Purified Water, Sodium Citrate

Section 55105-1 (55105-1)

Astringent

Section 55106-9 (55106-9)

Witch Hazel 50%

Section 59845-8 (59845-8)

Gently apply to affected areas by patting and then discard

Aer Traveler Packet Artwork (AER Traveler Packet Artwork)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)