Label: ISOPROPYL ALCOHOL WITH WINTERGREEN 50% solution
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NDC Code(s):
10565-007-04,
10565-007-08,
10565-007-16,
10565-007-32, view more10565-007-99
- Packager: Hydrox Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings For external use only
Flammable
- Keep away from fire or flame, heat, spark, electrical. Flash point 72°F.
- do not use with eletocautery procedures.
Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
When using this product
- do not get into eyes
- do not apply over large areas of the body
- do not use longer than 1 week unless directed by a doctor
Stop use and ask a doctor if condition persists or gets worse
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS AND PRECAUTIONS
- Inactive Ingredient
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ISOPROPYL ALCOHOL WITH WINTERGREEN 50%
isopropyl alcohol with wintergreen 50% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10565-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 50 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) METHYL SALICYLATE (UNII: LAV5U5022Y) PEG-75 LANOLIN (UNII: 09179OX7TB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10565-007-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2019 2 NDC:10565-007-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2019 3 NDC:10565-007-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2019 4 NDC:10565-007-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2019 5 NDC:10565-007-99 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 06/19/2019 Labeler - Hydrox Laboratories (025164302) Registrant - Hydrox Laboratories (025164302) Establishment Name Address ID/FEI Business Operations Hydrox Laboratories 025164302 manufacture(10565-007) , label(10565-007) , pack(10565-007)
