SELVAN85 by Terra Hydrochem Inc. SELVAN85 Hand Sanitizer

SELVAN85 by

Drug Labeling and Warnings

SELVAN85 by is a Otc medication manufactured, distributed, or labeled by Terra Hydrochem Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SELVAN85- benzalkonium chloride liquid 
Terra Hydrochem Inc.

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.

----------

SELVAN85 Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Warnings

For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if conditions persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Pump a small amount of product into palm of hand
• Rub thoroughly over all surfaces of both hands
• Rub hands together briskly until dry

Inactive Ingredients

Aloe Vera plus proprietary blend

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

59 mL NDC: 90095-001-02

3.63 L NDC: 9005-003-01

236 mL NDC: 90095-002-08

SELVAN85 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90095-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
1,3-BENZENEDISULFONIC ACID (UNII: 38TKY93G3H)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
GLYCOLIC ACID (UNII: 0WT12SX38S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90095-001-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2020
2	NDC: 90095-001-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/19/2020
3	NDC: 90095-001-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/19/2020	03/31/2022

Labeler - Terra Hydrochem Inc. (024444576)

Establishment
Name	Address	ID/FEI	Business Operations
Terra Hydrochem Inc.		024444576	manufacture(90095-001) , pack(90095-001) , label(90095-001)

Revised: 4/2023

Document Id: f8988458-05bf-be69-e053-6394a90ab032

34390-5

Set id: ac0fd1e3-afc8-f0e4-e053-2a95a90acabd

Version: 4

Effective Time: 20230405