GERIGENTLE ALCOHOL PADS- isopropyl alcohol cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Available from:

Geri-Gentle Corporation

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For preparation of skin prior to injection

Authorization status:

OTC monograph not final

Summary of Product characteristics

GERIGENTLE ALCOHOL PADS- ISOPROPYL ALCOHOL CLOTH
GERI-GENTLE CORPORATION
----------
GERIGENTLE ALCOHOL PADS
_DRUG FACTS_
_ACTIVE INGREDIENT_
Isopropyl Alcohol, 70% v/v
_PURPOSE_
Antiseptic
_USE_
For preparation of skin prior to injection
_WARNINGS_
FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.
DO NOT USE
with electrocautery procedures
in the eyes
on mucous membranes
on irritated skin.
STOP USE AND ASK A DOCTOR IF
irritation or redness develops.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control center
right away.
_DIRECTIONS_
Wipe injection site vigorously and discard.
_OTHER INFORMATION_
Store at room temperature 15-30°C (59-86°F)
_INACTIVE INGREDIENTS_
Purified water
PACKAGE LABELING:69771-013-01
PACKAGE LABELING:69771-013-10
PACKAGE LABELING:69771-013-05
GERIGENTLE ALCOHOL PADS
isopropyl alcohol cloth
Geri-Gentle Corporation
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69771-015
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL -
UNII:ND2M416302)
ISOPROPYL
ALCOHOL
70 mL
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:69771-
015-01
1 in 1 BOX
10/01/2023
1
0.045 mL in 1 PATCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
2
NDC:69771-
015-10
100 in 1 BOX
10/01/2023
2
0.045 mL in 1 PATCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
3
NDC:69771-
015-05
10 in 1 BOX
10/01/2023
3
0.045 mL in 1 PATCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
505G(a)(3)
10/01/2023
LABELER -
Geri-Gentle Corporation (080367686)
Revised: 11/2023