SPATHERAPY ANTIBACTERIAL PINEAPPLE- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Shalom International Corp
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
To decrease bacteria on the skin and clean hands. Recommended for repeated use.
Authorization status:
OTC monograph not final
Authorization number:
73025-152-01

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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

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

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

12/0 1/20 20

Shalom International Corp

Labeler -

Shalom International Corp (001384825)

Revised: 11/2020

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