Ultra Defense Sani Smart Moisturizing Lotion & Sanitizing Spray

Ultra Defense Sani Smart Moisturizing and Sanitizing by

Drug Labeling and Warnings

Ultra Defense Sani Smart Moisturizing and 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 MOISTURIZING AND SANITIZING- alcohol 
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 Moisturizing Lotion & 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 or 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 15-30 C (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

kit

ULTRA DEFENSE SANI SMART MOISTURIZING AND SANITIZING 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74177-853
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74177-853-011 in 1 KIT; Type 0: Not a Combination Product10/14/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 100 mL
Part 21 BOTTLE, PLASTIC 73 mL
Part 1 of 2
ULTRA DEFENSE SANI SMART HAND SANITIZING 
alcohol spray
Product Information
Item 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 Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/14/2020
Part 2 of 2
ULTRA DEFENSE SANI SMART MOISTURIZING HAND 
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRDICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
173 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
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
 

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