Label: TLCUO LEMON- peroxy acetic acid spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 74438-050-01 - Packager: KTL LTD
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated May 27, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
-
WARNINGS
1.Do not use the product on the following areas:
Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)
2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.
If symptoms such as rash, itching, edema, and skin irritation occur, please stop using it.
3.Other precautions
1) For external use only (do not swallow).2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.
3)Do not use in anal or vaginal areas as they may cause irritation.
4) Use only for the intended purposes.
4.Precautions for storage
1) Keep away from direct sunlight and do not expose the product to heating devices or flame.2) Keep out of reach of children and go to the hospital immediately if swallowed.
3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.
4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TLCUO LEMON
peroxy acetic acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74438-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERACETIC ACID (UNII: I6KPI2E1HD) (PERACETIC ACID - UNII:I6KPI2E1HD) PERACETIC ACID 0.26 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) LEMON OIL (UNII: I9GRO824LL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74438-050-01 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2020 Labeler - KTL LTD (694481741) Registrant - KTL LTD (694481741) Establishment Name Address ID/FEI Business Operations KTL LTD 694481741 manufacture(74438-050)