Forticept Blue Butter Antimicrobial Gel: Product Information

FORTICEPT BLUE BUTTER ANTIMICROBIAL GEL- benzethonium chloride and thymol gel
Lidan, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Benzethonium Chloride ………………………………………………………..0.1%
Thymol ……………………………………………………………………………0.1%

´╗┐Inactive ingredients:

Emollients, botanical extracts, and FD&C colors…………………………………………………….99.8%

Uses

Helps protect animal skin and supports healing of minor wounds, scrapes, burns, and lacerations, including pressure sores, ulcers, and cracked skin. Topical antiseptic to help decrease the risk of infection.

Rapid-acting with moderate duration of action.

Warnings

*For external use only *Not for human use *Keep out of reach of children.

When using this product — avoid eye contact. Stop use and ask a veterinarian: If condition worsens, symptoms last more than 7 days, or clear up and occur again within a few days.

Do not use on deep or puncture wounds, animal bites or serious burns unless directed by a veterinarian.

´╗┐Directions for use

Wash and dry affected skin. Put a thin layer of Forticept Blue Butter Gel on the affected skin. Cover with a clean or sterile bandage if practical or necessary. Repeat procedure twice daily or as needed until condition improves.

´╗┐Storage and handling

Keep container closed when not in use. Store at room temperature. Do not expose to temperatures below 32F/0o C or above 95F/35o C for extended periods of time.

FIRST AID

Eye contact: In case of contact, immediately rinse eyes with cool water for 15 minutes. Get medical attention if irritation continues.

Ingestion: If swallowed DO NOT induce vomiting unless directed to do so by medical personnel. If large quantities of this material are swallowed, call a poison control center immediately.

Blue Butter 4oz Top Label
(click image for full-size original)
Blue Butter 4oz Side Label
(click image for full-size original)

Blue Butter 8oz Label
(click image for full-size original)

FORTICEPT BLUE BUTTER ANTIMICROBIAL GEL
benzethonium chloride, thymol gel
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:72127-0702
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzethonium chloride (BENZETHONIUM) benzethonium chloride 1 g in 1000 g
thymol (THYMOL) thymol 1 g in 1000 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72127-0702-4 114 g in 1 CAN None
2 NDC:72127-0702-8 240 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/29/2016
Labeler — Lidan, Inc. (014456716)
Registrant — Lidan, Inc. (014456716)
Establishment
Name Address ID/FEI Operations
Cosco International, Inc. 016433141 api manufacture, analysis, manufacture, label, pack
Establishment
Name Address ID/FEI Operations
Pharmex Group, LLC 365309015 manufacture, label, pack, repack

Revised: 11/2020 Lidan, Inc.

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