Blackwork Numbing Lubricant 236 mL

CALEXOTICS Fuck Sauce Anal by

Drug Labeling and Warnings

CALEXOTICS Fuck Sauce Anal by is a Otc medication manufactured, distributed, or labeled by Private Label Productions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALEXOTICS FUCK SAUCE ANAL- numbing lubricant gel 
Private Label Productions 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.

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Blackwork Numbing Lubricant 236 mL

Active Ingredient(s)

Lidocaine HCI 3.5%

Purpose

External Analgesic

Use

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. ■ Keep this and all drugs out of reach of children. In case of accidential overdose, 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.

Directions

■ Apply to any area of the body where you desire extra moisture. Secure cap. ■ Apply externally to the desired area up to 6 times daily.

Keep out of reach of children.

Other information

Store at 20-25°C ( equals 68-77°F)

Inactive ingredients

Purified Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Citric Acid

Package Label - Principal Display Panel

Lubricant-image236236 mL: NDC: 77632-125-01

CALEXOTICS FUCK SAUCE ANAL 
numbing lubricant gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77632-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS3.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77632-125-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/31/2023
Labeler - Private Label Productions LLC (046278265)

Revised: 7/2023
Document Id: ffd479cd-3419-0b67-e053-6394a90a30c1
Set id: ffd4ab98-274a-497f-e053-6394a90a52aa
Version: 1
Effective Time: 20230706