Label: SALICYLIC ACID ACNE PATCHES- salicylic acid 0.5% patch
- NDC Code(s): 69139-120-01
- Packager: YIWU HAODING MEDICAL CO.,LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 15, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- INDICATIONS & USAGE
- QUESTIONS
-
DOSAGE & ADMINISTRATION
Directions
- Sensitivity test for new user
- Prior to first use, conduct a 24-hour patch test on a small area of your arm on clean, dry skin to determine skin reactivity.
- Proceed with normal usage only if irritation does not occur, as directed below.
- Cleanse face with soap and warm water to remove all traces of oil and dirt.
- Select a dot-shaped patch that is larger than the acne blemish and adhere the patch over the area to be treated.
- After 8 hours remove by gently peeling back and discarding.
- Cleanse the treated area and apply another patch if desired.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SALICYLIC ACID ACNE PATCHES
salicylic acid 0.5% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69139-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 mg in 100 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) styrene (UNII: 44LJ2U959V) HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB) MINERAL OIL (UNII: T5L8T28FGP) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69139-120-01 48 in 1 BOX 09/15/2022 1 23.1 mg in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/15/2022 Labeler - YIWU HAODING MEDICAL CO.,LTD (421362384) Establishment Name Address ID/FEI Business Operations YIWU HAODING MEDICAL CO.,LTD 421362384 manufacture(69139-120)
