AQUA SUNSET HAND SANITIZER - alcohol liquid 
Unique Holding 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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Drug Facts

Active Ingredient

Ethyl Alcohol 62%  


Purpose:

Sanitizer


Uses:

To decrease the bacteria on the skin that could cause disease. Recommended for repeated use.


Warnings:

For external use only-hands.
Use only as directed.
Excessive use or prolonged exposure may cause irritation to the skin.
Discontinue use if irritation, redness, or itching occurs.
Flammable. Keep away from heat and flame

When Using This Product:

Keep out of eyes. In case of contact with eyes, flush immediately with water and call a doctor.

Avoid contact with broken skin



Stop Use And Ask A Doctor if irritation or redness develops




Keep Out of Reach of Children:

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

Directions:

Put a thumb size amount in your palm and rub hands together briskly until dry

Other Information

Do not store in temperatures over 118F

Children under six years of age should be supervised while using this product.

May discolor certain fabrics



Inactive Ingredients

aloe barbadensis gel, carbomer, deionized water, Fragrance, glycerin, propylene glycol, D and C Blue No. 1, triethanolamine, and vitamin E, FD and C Yellow No. 5

lablabel

AQUA SUNSET HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25225-023(NDC:None)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R) 35.5998 g  in 100 g
Propylene Glycol (UNII: 6DC9Q167V3) 0.5 g  in 100 g
Glycerin (UNII: PDC6A3C0OX) 1 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 g  in 100 g
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.33 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.01 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK) 0.35 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 g  in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0001 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25225-023-0128 g in 1 BOTTLE, PLASTIC
2NDC:25225-023-0259 g in 1 BOTTLE, PLASTIC
3NDC:25225-023-04237 g in 1 BOTTLE, PLASTIC
4NDC:25225-023-05500 g in 1 BOTTLE, PLASTIC
5NDC:25225-023-03222 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/13/2010
Labeler - Unique Holding Group Inc (529047265)
Registrant - Unique Holding Group Inc (529047265)
Establishment
NameAddressID/FEIBusiness Operations
Unique Holding Group Inc529047265manufacture

Revised: 11/2010
Document Id: 24709e22-6de1-4e30-b4cc-8b8be9122b53
Set id: e2a4aa4a-6a19-4290-b619-54251b9a3611
Version: 1
Effective Time: 20101107
 
Unique Holding Group Inc