Blackwork Foam Wash 60 mL

Blackwork by

Drug Labeling and Warnings

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

Drug Details [pdf]

BLACKWORK- foaming lidocaine wash liquid 
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 Foam Wash 60 mL

Active Ingredient(s)

Benzalkonium Chloride 0.6% Antiseptic Lidocaine Hydrochloride 2.0%

Purpose

Antiseptic & External Analgesic

Use

■ For minor cuts, scrapes, and burns to help reduce the risk of infection and the temporary relief of pain and itching.

Warnings

■ For external use only. ■ Do not use in large quantities, particulary over raw surfaces or blistered areas. ■ Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns. ■ Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

Directions

■ Use to clean minor cuts, scrapes, and burns by thoroughly flushing the affected area and let air dry. ■ Children under 2 years of age: Do not use, consult a doctor. ■ Children under 2 years of age: Do not use, consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poinson Control Cennter immediately.

Other information

Store at 20-25°C ( equals 68-77°F)

Inactive ingredients

Purified Water, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice, Decyl Glucoside, Cetrimonium Chloride, Phenoxyethanol, Disodium EDTA

Package Label - Principal Display Panel

60 mL NDC: 77632-124-60

BLACKWORK 
foaming lidocaine wash liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77632-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.06 mg  in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77632-124-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/31/2023

Labeler - Private Label Productions LLC (046278265)

Revised: 7/2023

Document Id: ff9de62e-b92a-059d-e053-6394a90a8b15

34390-5

Set id: ff9de62e-b92b-059d-e053-6394a90a8b15

Version: 1

Effective Time: 20230703