CANDYLAND HAND SANITIZER AND LIP BALM- 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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Candyland Hand Sanitizer and Lip Balm Kit

Drug Facts

Active ingredient

Alcohol 69% v/v

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

For external use only

Flammable, keep away from fire and flames

When using this product

  • do not get into eyes.
  • if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

  • irritation and redness develop

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Yellow 5, Blue 1.

Company Information

MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC

2433 KNAPP ST. BROOKLYN, NY 11235

Product Packaging

CL 102 jpg

CANDYLAND HAND SANITIZER AND LIP BALM 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74177-967
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74177-967-011 in 1 KIT; Type 0: Not a Combination Product12/11/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 30 mL
Part 21 TUBE 3.4 g
Part 1 of 2
BERRY LOLLIPOP HAND SANITIZER 
alcohol gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/11/2020
Part 2 of 2
LIP BALM 
lipstick lipstick
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPOLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRCERESIN (UNII: Q1LS2UJO3A)  
INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13.4 g in 1 TUBE; 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 finalpart333A12/11/2020
Labeler - K7 Design Group Inc. (080357784)

Revised: 12/2020
Document Id: b66f6027-e18b-8f92-e053-2995a90a7b65
Set id: b66f6027-e18c-8f92-e053-2995a90a7b65
Version: 1
Effective Time: 20201214
 
K7 Design Group Inc.