Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
GFA Production (Xiamen) Co., Ltd.
TOPICAL
OTC DRUG
For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.
OTC monograph not final
INSECT STING RELIEF- BENZOCAINE, ALCOHOL SWAB GFA PRODUCTION (XIAMEN) CO., LTD. ---------- INSECT STING RELIEF PAD DRUG FACTS - INSECT STING RELIEF PAD ACTIVE INGREDIENT: Benzocaine, 6% w/v SD alcohol, 60% w/v PURPOSE: Topical Anesthetic Anesthetic USE: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites. _WARNINGS:_ For external use only. DO NOT USE: In eyes, on broken skin, deep puncture wounds. If unsual redness, swelling, irritation or other symptoms occur, consult a physician immediately. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Contrl Center right away. Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water INACTIVE INGREDIENTS: Purified water. PACKAGE LABELING: INSECT STING RELIEF benzocaine, alcohol swab PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:50814-041 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZ OCAINE 60 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 600 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:50814- 041-01 0.18 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 06/29/2018 2 NDC:50814- 041-02 0.53 mL in 1 POUCH; Type 0: Not a Combination Product 06/29/2018 3 NDC:50814- 041-03 0.225 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 01/01/2019 GFA Production (Xiamen) Co., Ltd. MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug M017 06/29/2018 LABELER - GFA Production (Xiamen) Co., Ltd. (421256261) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS GFA Production (Xiamen) Co., Ltd. 421256261 manu Lesen Sie das vollständige Dokument