SPATHERAPY ANTI-BACTERIAL HAND LEMON CITRUS- 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:
Use: To decrease bacteria on the skin and clean hands. Recommended for repeated use. Purpose: Antibacterial
Authorization status:
OTC monograph not final
Authorization number:
73025-050-01

SPATHERAPY ANTI-BACTERIAL HAND LEMON CITRUS- 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 Anti-bacterial Hand Gel Lemon Citrus

Drug Facts

Active Ingredient

Alcohol Denat 60% w/w

Purpos e

Antibacterial

Antibacterial

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

Warnings

For external use only. Flammable, keep away from fire or flame.

Keep out of reach of children.

For external use only. Flammable, keep away from fire or flame.

Do not get into eye.

If contact occurs, rinse thoroughly with water.

Discontinue use

if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

Directions

Apply to hands until thoroughly wet. Rubvigorously until dry.

Inactive Ingredients

Water(Aqua), PEG-40 Hydrogenated Caster Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Fragrance(Parfum), Sodium Hydroxide, Tocopheryl

Acetate, Simmndsia Chinensis (jojoba) Seed Wax, FD&C Yellow 5(CI 19140), FD&C Red 4(CI 14700)

Package Labeling:

SPATHERAPY ANTI-BACTERIAL HAND LEMON CITRUS

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 25-0 50

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 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)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Shalom International Corp

SIMMO NDSIA CHINENSIS SEED WAX (UNII: 47X6 Y9 FJJ2)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

FD&C RED NO . 4 (UNII: X3W0 AM1JLX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 25-0 50 -0 1

30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /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

0 6 /0 1/20 20

Labeler -

Shalom International Corp (001384825)

Revised: 4/2020

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