B-SURE TRAVELER TOWELETTE- b-sure traveler solution
Birchwood Laboratories LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

B-SURE Traveler Drug Facts

Warnings

For external use only. Stop use and ask doctor if rectal bleeding or continued irratation occurs.

Directions

Gently apply to affected areas by patting and then discard.

Inactive Ingredients

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

Purpose

Astringent

Keep Out of Reach of Children

Keep out of reach of children.

Uses

Temporary relief of anal itching & burning.

Active Ingredients

Witch Hazel 50%

B-SURE Packet

B-SURE TRAVELER TOWELETTE
b-sure traveler solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50289-9250
Route of Administration	RECTAL, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.5 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.125 g in 1 g
SODIUM CITRATE (UNII: 1Q73Q2JULR)	0.034 g in 1 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.026 g in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.012 g in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.0009 g in 1 g
WATER (UNII: 059QF0KO0R)	0.302 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50289-9250-1	4 g in 1 PACKET; Type 0: Not a Combination Product	01/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M015	01/20/2020

Labeler - Birchwood Laboratories LLC (096488432)

Name	Address	ID/FEI	Business Operations
Establishment
Birchwood Laboratories LLC		096488432	manufacture(50289-9250)

Revised: 1/2023

Document Id: f1e99045-dfe8-8de0-e053-2a95a90a9add

Set id: e1a5da94-6a1a-497b-a737-1c1541bf0404

Version: 5

Effective Time: 20230110

Birchwood Laboratories LLC