RENEW SKIN REPAIR- otc skin protectant drug products cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

Dermarite Industries LLC

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE 0.015 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant Temporarily protects and helps relieve chapped or cracked skin. Benificial for face, hands, body, and legs.

Authorization status:

OTC monograph final

Summary of Product characteristics

RENEW SKIN REPAIR- OTC SKIN PROTECTANT DRUG PRODUCTS CREAM
DERMARITE INDUSTRIES LLC
_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 LISTING: RENEW SKIN REPAIR CREAM
ACTIVE INGREDIENT:
Dimethicone 1.5%
PURPOS E:
Skin Protectant
US ES :
Temporarily protects and helps relieve chapped or cracked skin.
Benificial for face, hands, body, and
legs.
WARNINGS :
FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES. In case of contact, flush thoroughly with
water.
STOP USE AND ASK A DOCTOR IF condition worsens or does not improve
within 7 days and if symptoms
clear up and occur again within a few days.
Do not use on deep or punctured wounds, animal bites, or serius burns.
WARNINGS :
KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion contact
physician or Poison Control
Center right away.
DIRECTIONS :
Apply cream liberally as needed.
OTHER INFORMATION:
Store at room temperature (59
- 86
F)
You may report a serious adverse event to DermaRite Industries, PO Box
7209, North Bergen, NJ
07047
INACTIVE INFREDIENTS:
Water, Olea Europaea(Olive) Oil, Zea Mays (Corn) Oil, Canola Oil,
Stearic Acid, glyceryl Stearate,
PEG-100 Stearate, Propylene Glycol, Triethanolamine, Aloe Barbadensis
Leaf Juice, Glycerin,
Butylparaben, Ethylparaben, Isobutylparaben, methylparaben,
Phenoxyethanol, propylparaben, Citrus
Aurantium Dulcis (orange) Peel Oil, Anthemis Nobilis Flower Oil,
Lavandula Officinalis (lavender)
Oil, Fragrance, Cetearyl Alcohol, Carbomer, Ascorbyl Palmitate,
Disodium EDTA, Tocopheryl
Acetate, Niacinamide, Retinyl Palmitate, Cholecalciferol, Pyridoxine
HCL
o
o
QUES TIONS ?
Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.
PACKAGE LABEL PRINCIPAL DISPLAY PANEL
RENEW SKIN REPAIR
otc skin protectant drug products cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 19 24-40 5
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY