EQUATE MEDICATED DRY AND ITCH- dimethicone, menthol lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

WAL-MART STORES INC

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE 0.05 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporarily protects and helps relieve chapped or cracked skin. Temporarily relieves itching associated with: - minor skin irritations - minor burns - rashes due to poison ivy, oak and sumac - insect bites - sunburn

Authorization status:

OTC monograph final

Summary of Product characteristics

EQUATE MEDICATED DRY AND ITCH- DIMETHICONE, MENTHOL LOTION
WAL-MART STORES 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 INGREDIENT
Dimethicone 5.0%
PURPOS E
Skin Protectant
ACTIVE INGREDIENT
Menthol 0.5%
PURPOS E
Anti-Itch
US ES
temporarily protects and helps relieve chapped or cracked skin.
Temporarily relieves itching
associated with:
minor skin irritations
minor burns
rashes due to poison ivy, oak and sumac
insect bites
sunburn
WARNINGS
For external use only.
WHEN USING THIS PRODUCT
avoid contact with eyes. If contact occurs, rinse eyes thoroughly with
water.
Do not use on
deep or puncture wounds
animal bites
serious burns
_Stop use and ask a doctor if_
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few days
redness, irritation, swelling or pain persists or increases
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, get medical help or contact a Poison
Control Center immediately.
DIRECTIONS
apply as needed.
OTHER INFORMATION
store at room temperature.
INACTIVE INGREDIENTS
Water (Aqua), Cetearyl Alcohol, Cetyl Alcohol, Polysorbate 60,
Distearyldimonium Chloride,
Glycerin, Stearamidopropyl PG-Dimonium Chloride Phosphate, Petrolatum,
Aloe Barbadensis Leaf
Juice, Stearyl Alcohol, Propylene Glycol, Steareth-2, Steareth-21,
Tocopheryl Acetate, Tetrasodium
EDTA, Diazolidinyl Urea, Propylparaben, Methylparaben, Fragrance
(Parfum).
LABEL COPY
EQUATE MEDICATED DRY AND ITCH
dimethicone, menthol lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 0 35-333
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)
DIMETHICONE
0 .0 5 g in 1 g
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
0 .0 0 5 g in 1 g
IN