Miss Spa: Package Insert and Label Information

MISS SPA — alcohol 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.

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
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MISS SPA
hand sanitiser gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61238-1125
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 554 mL in 554 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
POLYACRYLIC ACID (250000 MW)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61)
ALOE VERA LEAF
TOCOPHERYL RETINOATE
DISODIUM (ETHOXYCARBONYL)PHOSPHONATE
SODIUM HYDRIDE
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
FD&C RED NO. 3
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61238-1125-1 29 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 11/15/2013
Labeler — Oriental Home Sense Co., Ltd. (668448004)
Establishment
Name Address ID/FEI Operations
Oriental Home Sense Co., Ltd. 668448004 manufacture (61238-1125)

Revised: 11/2013 Oriental Home Sense Co., Ltd.

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