Ultra Defense Sani Smart Hand Sanitizing Spray

Ultra Defense Sani Smart Hand Sanitizing by

Drug Labeling and Warnings

Ultra Defense Sani Smart Hand Sanitizing by is a Otc medication manufactured, distributed, or labeled by K7 Design Group Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRA DEFENSE SANI SMART HAND SANITIZING- alcohol spray 
K7 Design Group Inc.

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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Ultra Defense Sani Smart Hand Sanitizing Spray

Drug Facts

Active ingredient

Alcohol Denat. 70%

Purpose

Antiseptic

Uses

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire and flame.

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest

Stop use and ask a doctor if

  • irritation and redness develop and persist for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Spray directly on hands and rub in thoroughly
  • For children under 6, use adult supervision
  • Not recommended for infants

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Glycerin, Fragrance.

Company Information

MANUFACTURED FOR & DISTRIBUTED BY K7 DESIGN GROUP LLC.

2433 KNAPP STREET, BROOKLYN, NY 11235

ORIGIN: CHINA

Product Packaging - 100 mL

spray 100ml

ULTRA DEFENSE SANI SMART HAND SANITIZING 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74177-852
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74177-852-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/14/2020
2NDC: 74177-852-0210 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/14/2020
3NDC: 74177-852-033 in 1 PACKAGE10/14/2020
310 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/14/202010/14/2020
Labeler - K7 Design Group Inc. (080357784)

Revised: 10/2020
Document Id: b2d4873c-02e4-5bdd-e053-2a95a90a6d77
Set id: b1a58063-c8d7-7acf-e053-2995a90a8d17
Version: 2
Effective Time: 20201029
 
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