FDA.reportPublic FDA data

ACL11SP NERVE BLOCK

Manufacturer
Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date
2013-06-25
Label type
MEDICAL DEVICE
Version
2
Source
full-release
Hydrated at
2026-06-01 02:47:42

Key Label Information#

Warnings

WARNINGS SECTION

Povidone-iodine 10% Antiseptic Warnings Do not use if allergic to iodine in the eyes For external use only Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases infection occurs Avoid pooling beneath patient Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Other Label Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

Label Images#

Povidone Iodine Solution
Povidone Iodine Solution
ACL11SP
ACL11SP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN2
312564povidone-iodine 100 MG/ML Topical SolutionSCD2
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55553-436-02ACL11SP NERVE BLOCK30 in 1 CASEKIT302
55553-436-02ACL11SP NERVE BLOCK1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-0001ACL11SP NERVE BLOCK () KIT [CLINT PHARMACEUTICALS, INC.]2Legacy NDC20130626_8bd1f2a9-e7fa-402c-893f-e186db087562.zip
55553-436ACL11SP NERVE BLOCK () KIT [CLINT PHARMACEUTICALS, INC.]22 package rows20130626_8bd1f2a9-e7fa-402c-893f-e186db087562.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0001-1ML - Milliliter52380-0001edd25a2a-aabd-433e-b5a8-ef9471c1b24412012-07-24
52380-0001-3ML - Milliliter52380-00019f05eb45-3f8e-4fd9-814a-476eb917bf5c12021-11-09
52380-0001-5EA - Each52380-00019755da7f-19a8-4706-8c70-17752ffe417512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M2
IODINEACTIVE MOIETY9679TC07X42
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA742
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55553-43655553-436-02
52380-000152380-0001-3

Ingredients#

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM HYDROXIDE55X04QC32IIACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT

Complete SPL Sections#

DESCRIPTION SECTION

DESCRIPTION SECTION

APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution [Aplicare, Inc.] 3/4 Ounce Povidone Iodine Packet

WARNINGS SECTION

WARNINGS SECTION

Povidone-iodine 10% Antiseptic Warnings Do not use if allergic to iodine in the eyes For external use only Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases infection occurs Avoid pooling beneath patient Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

Source Document#

Source XML