SPATHERAPY ANTIBACTERIAL PINEAPPLE- alcohol gel

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

제공처:

Shalom International Corp

관리 경로:

TOPICAL

처방전 유형:

OTC DRUG

치료 징후:

To decrease bacteria on the skin and clean hands. Recommended for repeated use.

승인 상태:

OTC monograph not final

제품 특성 요약

SPATHERAPY ANTIBACTERIAL PINEAPPLE- ALCOHOL GEL
SHALOM INTERNATIONAL CORP
_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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SPATHERAPY ANTIBACTERIAL HAND GEL PINEAPPLE
_DRUG FACTS_
_ACTIVE INGREDIENT_
Alcohol Denat. 62%
_PURPOSE_
Antibacterial
_USE_
To decrease bacteria on the skin and clean hands. Recommended for
repeated use.
_WARNINGS_
FOR EXTERNAL USE ONLY.
FLAMMABLE, KEEP AWAY FROM FLAMES.
WHEN USING THIS PRODUCT
do not get into eye. If contact occurs, rinse thoroughly with water.
STOP USE AND ASK A DOCTOR IF
irritation or redness develop or persists for more than 72 hours
KEEP OUT OF REACH OF CHILDREN.
_DIRECTIONS_
Apply to hands until thoroughly wet. Rub vigorously until dry.
_INACTIVE INGREDIENTS_
Water, PEG-40 Hydrogenated Cater Oil, Acrylates/ C10-30 Alkyl Acrylate
Crosspolymer. DMDM
Hydantoin, Fragrance (Parfum), Sodium Hydroxide, Tocopherol Acetate.
FD&C Yellow 5, FD&C Blue
1.
PACKAGE LABELING:
SPATHERAPY ANTIBACTERIAL PINEAPPLE
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:730 25-152
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
0 .6 2 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F)
CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII:
59 TL3WG5CO)
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:730 25-152-0 1
30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
12/0 1/20 20
MARKETING INFORMATION