MISS SPA - hand sanitiser gel 
Oriental Home Sense Co., Ltd.

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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Miss Spa Hand Sanitiser

ACTIVE INGREDIENT: ETHYL ALCOHOL 55.4% PURPOSE ANTISEPTIC

ANTISEPTIC

USES: TO HELP REDUCE BACTERIA ON THE HANDS.

WARNING: FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES AND LIPS. IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS

KEEP OUT OF REACH OF CHILDREN, IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS: WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

INACTIVE INGREDIENTS: WATER, PROPYLENE GLYCOL, FRAGRANCE, POLYACRYLIC ACID, HYDROGENATED JOJOBA OIL, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, DISODIUM EDTA, SODIUM HYDROXIDE. MAY CONTAIN: FD&C BLUE NO. 1(CI 42090), D&C RED NO. 33(CI 17200), FD&C RED NO. 40(CI 16035), FD&C YELLOW NO. 5 (CI 19140)

Miss Spa Hand Sanitiser

image description
MISS SPA  
hand sanitiser gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61238-1125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL554 mL  in 554 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
DISODIUM (ETHOXYCARBONYL)PHOSPHONATE (UNII: 0YFB1C22IN)  
SODIUM HYDRIDE (UNII: 23J3BHR95O)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61238-1125-129 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/15/2013
Labeler - Oriental Home Sense Co., Ltd. (668448004)
Establishment
NameAddressID/FEIBusiness Operations
Oriental Home Sense Co., Ltd.668448004manufacture(61238-1125)

Revised: 11/2013
Document Id: ff852f31-41e7-4569-8849-29fa82215edb
Set id: 8ce8124a-73e0-44cc-a804-9a470ba60e41
Version: 1
Effective Time: 20131114
 
Oriental Home Sense Co., Ltd.