SM SWABALPHA by shammah pharm Drug Facts

Drug Details [pdf]

SM SWABALPHA- isopropyl alcohol liquid
shammah pharm

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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Drug Facts

isopropyl alcohol

sterilization of hands, skin and so on

KEEP OUT OF REACH OF THE CHILDREN

take appropriate amount on the hand, rub and dry well

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

for external use only

purified water, non-woven fabric

label

SM SWABALPHA
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75697-0004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 75697-0004-2	100 in 1 PACKAGE	07/31/2020	01/17/2021
1	NDC: 75697-0004-1	0.7 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/31/2020	01/17/2021

Labeler - shammah pharm (695539251)

Registrant - shammah pharm (695539251)

Name	Address	ID/FEI	Business Operations
Establishment
shammah pharm		695539251	manufacture(75697-0004)

Revised: 1/2021

Document Id: b9174308-4ef8-1692-e053-2995a90ae13e

Set id: abaec55e-04b1-3ea5-e053-2a95a90a28f3

Version: 4

Effective Time: 20210117