Country: United States
Language: English
Source: NLM (National Library of Medicine)
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)
Genuine Virgin Aloe Corporation
TOPICAL
OTC DRUG
PURPOSE SKIN PROTECTANT USES TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO: - ECZEMA - RASHES DO NOT USE - ON DEEP PUNCTURE WOUNDS - ON INFECTIONS - ON LACERATIONS 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.
OTC monograph final
ECZEMA FAST HEALING- OATMEAL LOTION GENUINE VIRGIN ALOE CORPORATION _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._ ---------- ACTIVE INGREDIENT COLLOIDAL OATMEAL 1.5% PURPOSE SKIN PROTECTANT USES TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO: ECZEMA RASHES WARNINGS FOR EXTERNAL USE ONLY DO NOT USE ON DEEP PUNCTURE WOUNDS ON INFECTIONS ON LACERATIONS WHEN USING THIS PRODUCT DO NOT GET INTO 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 CONTACT A POISON CONTROL CENTER IMMEDIATELY. DIRECTIONS: APPLY TWICE A DAY OR AS NEEDED. Inactive ingredients: aleurites moluccana seed (kukui nut) oil,allantoin, aloe barbadensis (AP4® genuine virgin organic aloe vera) leaf extract, arnica (montana flower) extract, beeswax, butyrospermum parkii (shea butter), caprylic capric triglyceride, cetearyl alcohol, cetyl alcohol, dimethicone, disodium EDTA, glycerin, panthenol (pro vitamin B5), petrolatum, phenoxyethanol, polysorbate 60, retinyl palmitate (vitamin A), sodium hyaluronate, sodium PCA, squalane, tocopheryl acetate (vitamin E), triethanolamine, urea, zinc PCA ECZEMA FAST HEALING oatmeal lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:10 738 -10 2 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O ATMEAL (UNII: 8 PI54V6 6 3Y) (OATMEAL - UNII:8 PI54V6 6 3Y) OATMEAL 1.5 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH KUKUI NUT O IL (UNII: TP11QR7B8 R) ALLANTO IN (UNII: 344S277G0 Z) ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X) ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ) YELLO W WAX (UNII: 2ZA36 H0 S2V) SHEA BUTTER (UNII: K49 155WL9 Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U) CETO STEARYL ALCO Read the complete document