Country: United States
Language: English
Source: NLM (National Library of Medicine)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)
Ashahi Chemicals USA LLC
TOPICAL
OTC DRUG
Antiseptic, hand sanitizer Hand and surface treatment to help reduce bacteria that potentially can cause disease. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC monograph not final
CITRIC ACID- CITRIC ACID LIQUID ASHAHI CHEMICALS USA 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._ ---------- CITRIC ACID N/A ACTIVE INGREDIENT(S) Citric Acid 3.5% v/v. Purpose: Antiseptic PURPOS E Antiseptic, hand sanitizer US E Hand and surface treatment to help reduce bacteria that potentially can cause disease. WARNINGS For external use only. Flammable. Keep away from heat or flame DO NOT USE in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. OTHER INFORMATION Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) INACTIVE INGREDIENTS purified water USP PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 946 mL NDC: 80866-001-01 3785 mL NDC: 80866-001-02 CITRIC ACID citric acid liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:8 0 8 6 6 -0 0 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 5.6 g in 10 0 mL INACTIVE INGREDIENTS Ashahi Chemicals USA LLC INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # Read the complete document