B-SURE Traveler Towelette: Package Insert and Label Information

B-SURE TRAVELER TOWELETTE- witch hazel 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.

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 Packet
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 0.5 g in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.125 g in 1 g
SODIUM CITRATE 0.034 g in 1 g
ANHYDROUS CITRIC ACID 0.026 g in 1 g
METHYLPARABEN 0.012 g in 1 g
BENZALKONIUM CHLORIDE 0.0009 g in 1 g
WATER 0.302 g in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50289-9250-1 4 g in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 01/20/2020
Labeler — Birchwood Laboratories LLC (096488432)
Establishment
Name Address ID/FEI Operations
Birchwood Laboratories LLC 096488432 manufacture (50289-9250)

Revised: 01/2021 Birchwood Laboratories LLC

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