Over-the-counter drug · OTC MONOGRAPH NOT FINAL

Instant Hand Sanitizer (Alcohol) NDC 61010-5111

Alcohol 665 mg/L · Gel · Topical · Safetec of America, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)61010-5111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61010-5111Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
61010-5111-061010511100610105111001026 L in 1 CONTAINER (61010-5111-0)Marketed from Aug 7, 2013

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Instant Hand Sanitizer
Generic name (nonproprietary)
alcohol
Active ingredients
Alcohol — 665 mg/L
Dosage form
Gel
Route
Topical
Labeler
Safetec of America, Inc.NDC labeler code 61010
Product type
Over-the-counter drug
Marketing category
OTC monograph (not final)Application part333E
Marketing start
Listing expires
Identifiers
Product ID 61010-5111_d6138e2e-98eb-4fc7-bea2-600dcc8a4f57SPL ID d6138e2e-98eb-4fc7-bea2-600dcc8a4f57SPL set ID f9e30645-491b-4f54-acfd-f863ee235607RxCUI 616762UNII 3K9958V90M

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N461010511100 followed by a unit qualifier and the quantity

Package 61010-5111-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection recommended for repeated use

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61010-5111

What is NDC 61010-5111?
61010-5111 is the product NDC for Instant Hand Sanitizer (alcohol), Alcohol 665 mg/L gel, listed with the FDA by Safetec of America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Instant Hand Sanitizer (Alcohol).
What is the active ingredient?
Alcohol.
Who is the labeler?
Safetec of America, Inc., NDC labeler code 61010. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Instant Hand Sanitizer?
27 other product NDCs are listed under this name. See all Instant Hand Sanitizer NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Instant Hand Sanitizer NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Instant Hand SanitizerAlcohol 70 mL/100mLLiquidTopicalNINGBO MEITELI COSMETICS CO., LTD75541-01675541-0016-0175541-0016-02
Instant Hand SanitizerAlcohol 70 mL/100mLSprayTopicalRaining Rose, Inc65692-208465692-2084-01
Instant Hand Sanitizerhand sanitizerAlcohol 70 mL/100mLLiquidTopicalRaining Rose, Inc.65692-208365692-2083-01
Instant Hand SanitizeralcoholAlcohol .7 mL/mLSprayTopicalASC Marketing LTD73145-01073145-0010-0173145-0010-02
Instant HAND SANITIZERalcoholAlcohol .75 mL/mLGelTopicalXact Xpressions79524-00079524-0000-0279524-0000-08
Instant Hand SanitizeralcoholAlcohol .7 mL/mLGelTopicalABC Compounding Co., Inc.62257-06162257-0061-1162257-0061-1462257-0061-17+1 more
Instant Hand SanitizerAlcohol 67 mL/100mLLiquidTopicalClark Core Services, LLC81551-69381551-0693-03
Instant Hand SanitizeralcoholAlcohol .65 mL/mLGelTopicalICARCOVER INC.75248-00075248-0000-00
Instant Hand Sanitizerethyl alcoholAlcohol 62 mL/100mLSprayTopicalHillyard GMP76402-42276402-0422-0276402-0422-0376402-0422-31
Instant Hand Sanitizerethyl alcoholAlcohol 62 mL/100mLGelTopicalRejoice International Corp.57337-08257337-0082-01

All 28 Instant Hand Sanitizer NDCs

Other NDCs under part333E

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under part333E
ProductStrengthForm · routeLabelerProduct NDC
Afassco Hand SanitizeralcoholAlcohol 62 mL/100mLLiquidTopicalJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.71734-206
Alcohol WipesalcoholAlcohol .31 mL/mLClothTopicalJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.71734-202
Antimicrobial Face Body Washbenzethonium chloride liquidBenzethonium chloride .2 g/100gLiquidTopicalBio-Medical & Pharmaceutical Manufacturing Corporation37945-902
DEFENSE Hand Sanitizerisopropyl alcoholIsopropyl alcohol .75 mL/mLLiquidTopicalWalla Walla Environmental, Inc.80579-000
DEFENSE Hand Sanitizerisopropyl alcoholIsopropyl alcohol .75 mL/mLLiquidTopicalWalla Walla Environmental, Inc.80579-001
Discount Drug Mart Vitamin E Hand Sanitizerethyl alcoholAlcohol 650 mg/mLLiquidTopicalDiscount Drug Mart53943-022
Freeman Packaging Hand SanitizeralcoholAlcohol 62 mL/100mLLiquidTopicalJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.71734-201
Hand Cleanse - Strawberry PomegranatetriclosanTriclosan 7.5 mg/500mgGelTopicalChina Ningbo Shangge Cosmetic Technology Corp.58503-011
Hand SanitizerAlcohol .62 mL/mLGelTopicalLS Promotions Inc.72449-100
Harris Teeter Spring Fresh Body Washbenzalkonium chlorideBenzalkonium chloride 1.3 mg/mLLiquidTopicalHarris Teeter72036-801
Isopropyl AlcoholalcoholAlcohol 70 mL/100mLSprayTopicalZee Medical35418-402
KidzStuff Hand SanitizeralcoholAlcohol 62 g/100gLiquidTopicalJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.71734-204
ONID WipeethanolAlcohol 75 mL/100mLSwabTopicalONID Technology Corp71441-180

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