Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Medline Industries, Inc.
TOPICAL
OTC DRUG
Skin Protectant - temporarily protects and helps relieve chapped or cracked skin - protects minor skin irritation associated with perineal dermatitis
OTC monograph final
READYBATH TPC TOTAL PERINEAL CARE- DIMETHICONE CLOTH READYBATH TPC- DIMETHICONE CLOTH READYCLEANSE CLEANSING WIPES- DIMETHICONE CLOTH ALOETOUCH PREMIUM SPUNLACE CLEANSING CLOTHS- DIMETHICONE CLOTH ALOETOUCH PREMIUM SPUNLACE- DIMETHICONE CLOTH READYFLUSH XLARGE PERSONAL CLEANSING CLOTHS- DIMETHICONE CLOTH MEDLINE INDUSTRIES, 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._ ---------- READYFLUSH(R) PROTECT _ACTIVE INGREDIENT_ Dimethicone 3.2% _PURPOSE_ Skin Protectant _USES_ temporarily protects and helps relieve chapped or cracked skin protects minor skin irritation associated with perineal dermatitis _WARNINGS_ FOR EXTERNAL USE ONLY DO NOT USE ON deep or puncture wounds animal bites serious burns WHEN USING THIS PRODUCT avoid direct contact with eyes STOP USE AND ASK A DOCTOR IF condition worsens symptoms last more than 7 days or clear up and occur again within a few days KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or consult a Poison Control Center right away. _DIRECTIONS_ Open package as designated Remove cloths and thoroughly cleanse soiled area Apply as needed Dispose of cloth in waste receptacle _OTHER INFORMATION_ Protect from freezing, avoid excessive heat Keep lid tightly sealed Not made with Natural Rubber Latex Do not flush Cloth: made of Rayon/Polyester _INACTIVE INGREDIENTS_ Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Citric Acid, Cocamidopropyl PG- Dimonium Chloride Phosphate, Disodium EDTA, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Simethicone, Sodium Benzoate, Polysorbate 20, Water (Aqua) ACTIVE PACKAGE LABEL 53329-060 DEACTIVATED PACKAGE LABEL 53329-061 DEACTIVATED PACKAGE LABEL 53329-062 DEACTIVATED PACKAGE LABEL 53329-063 DEACTIVATED PACKAGE LABEL 53329-065 DEACTIVATED PACKAGE LABEL 53329-066 READYBATH TPC TOTAL PERINEAL CARE dimethicone cloth PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM COD Read the complete document