DERMA GRAN- aluminium hydroxide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALGELDRATE (UNII: 03J11K103C) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)

Available from:

Derma Sciences Canada, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant - Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac. - For the temporary protection, comfort and lubrication of minor skin irritations such as intertrigo, chafing, galling, rubbing or friction.

Authorization status:

OTC monograph final

Summary of Product characteristics

DERMA GRAN - ALUMINIUM HYDROXIDE OINTMENT
DERMA SCIENCES CANADA, INC.
_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._
----------
DRUG FACTS
ACTIVE INGREDIENTS:
Aluminium Hydroxide Gel 0.275%
PURPOS E
Skin Protectant
US ES :
Dries the oozing, and weeping of poison ivy, poison oak, or poison
sumac.
For the temporary protection, comfort and lubrication of minor skin
irritations such as intertrigo,
chafing, galling, rubbing or friction.
WARNINGS :
For external use only.
Avoid contact with eyes.
Not to be applied over deep or puncture wounds, infections or
lacerations. CONSULT A PHYSICIAN.
If condition worsens or does not improve within 7 days stop use and
CONSULT A PHYSICIAN.
DO NOT USE ON
children under 6 months of age without consulting a physician.
KEEP THIS AND ALL MEDICINES OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Cleanse area and dry thoroughly. Apply as needed, directly to the
affected area.
OTHER INGREDIENTS:
Calcium carbonate, Lanolin, Magnesium hydroxide, Methlyparaben,
Petrolatum, Propylene glycol,
Propylparaben, Sodium Chloride, Sodium Lauryl Sulfate, Stearyl
alcohol, Vitamin A Palmitate, Water,
Zinc Chloride.
CUSTOMER STORAGE:
Store at a Controlled Room Temperature 15-30 (59-86 F)
PRINCIPAL DISPLAY PANEL
DERMA GRAN
OINTMENT
NDC 64772-126-36
pH Balanced
Skin Protectant
Latex Free
4 FL OZ (113 g)
o
o
DERMA GRAN
OINTMENT
NDC 64771-126-34
pH Balanced
Skin Protectant
Latex Free
DERMA GRAN
aluminium hydroxide ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 4772-126
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Derma Sciences Canada, Inc.
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALGELDRATE (UNII: 0 3J11K10 3C) (ALUMINUM HYDROXIDE - UNII:5QB0 T2IUN0
)
ALGELDRATE
0 .275 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG