DERMAGEL CLEAR- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Inopak. Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Antiseptic Uses - To decrease bacteria on the skin that potentially can cause disease. - Recommended for repeated use.

Authorization status:

OTC monograph not final

Summary of Product characteristics

DERMAGEL CLEAR- ALCOHOL GEL
INOPAK. LTD
_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._
----------
DERMAGEL CLEAR HAND SANITIZING GEL
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl Alcohol 70% v/v
_PURPOSE_
Antiseptic
_USES_
To decrease bacteria on the skin that potentially can cause disease.
Recommended for repeated use.
_WARNINGS_
Flammable, keep away from heat or flame.
For external use only.
Keep out of eyes, ears or mouth. In case of eye contact, flush with
water.
STOP USE AND ASK A DOCTOR if irritation and redness develop or if
condition persists
more than 72 hours.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away. Children should be supervised by an adult
when using this
product.
_DIRECTIONS_
Apply sufficient amount of product to your palm to cover both hands.
Rub until dry.
_OTHER INFORMATION_
May discolor certain fabrics and surfaces
_INACTIVE INGREDIENTS_
Acrylates/C10/30 Alkyl Acrylate Crosspolymer, PEG/PPG-18/18
Dimethicone,
Triethanolamine, Vitamin E, Water
QUESTIONS?
Call: 1-800-762-7725 or visit our website: www.inopak.com
NOT TESTED ON ANIMALS
INOPAK, LTD.
Ringwood, NJ 07456
DERMAGEL CLEAR
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:58575-131
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
70 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
(UNII:
132584PQMO)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:58575-
131-08
237 mL in 1 BOTTLE, PUMP; Type 0: Not a
Combination Prod