BOTTOMS UP- lidocaine liquid

Bottoms Up by

Drug Labeling and Warnings

Bottoms Up by is a Otc medication manufactured, distributed, or labeled by WSM Investment LLC dba Topco Sales, WSM Investment LLC. Topco Sales. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 5%

PURPOSE

Anorectal

INDICATIONS & USAGE

For temporary relief of pain, soreness, or burning in the perianal area.

WARNINGS

• For external use only. Do not use this product with a mechanical device.
• Certain persons can develop allergic reactions to ingredients in this product.

If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

• Do not exceed the daily recommended dosage
• In case of any bleeding, discontinue use and consult a doctor.
• Avoid contact with eyes, in case of eye contact, flush with water.

KEEP OUT OF REACH OF CHILDREN

• Keep this and all drugs out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
• As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.

DOSAGE & ADMINISTRATION

• Cleanse affected area with mild soap and water.
• Gently dry by patting or blotting with soft cloth or tissue before application.
• Apply externally to the affected area up to 6 times daily.

OTHER SAFETY INFORMATION

• Store at room temperature 20-25°C (68-77°F).
• Tamper-Evident: Do not use if tamper evident seal under cap is broken or missing.

INACTIVE INGREDIENT

Cellulose Gum, Diazolidinyl Urea, Glycerin, Isopentyldiol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water (Aqua).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOTTOMS UP 
lidocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69797-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	3.4 g  in 68 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69797-103-01	68 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2017
2	NDC: 69797-103-02	186 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/15/2017

Labeler - WSM Investment LLC dba Topco Sales (040346439)

Establishment
Name	Address	ID/FEI	Business Operations
WSM Investment LLC. Topco Sales		040346439	manufacture(69797-103)