Label: PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68121-002-01 - Packager: PATCOS COSMETICS (INDIA) PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 7, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- EXTRA INFORMATION ON FRONT LABEL :
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
- If taken internally serious gastric disturbances will result.
Flammable : keep away from fire or flame ,heat, spark ,electrical.
Ask a doctor before use for deep or puncture wounds, animal bites or serious burns.
When using this product : do not get into eyes ,do not inhale ,do not apply over large area of the body ,do not use longer than 1 week.
Stop use and ask a doctor if condition persist or get worse.
Keep out of reach of children
If swallowed ,get medical help or contact a Poison Control Center right away.
Caution –
- Fumes can be acutely irritating to skin ,eyes and the respiratory system.
- Do not apply to irritated skin or if excessive irritation develops.
- Avoid getting into eyes or mucus membranes .Avoid inhaling this product.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients
- Product Image
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INGREDIENTS AND APPEARANCE
PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68121-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL SALICYLATE (UNII: LAV5U5022Y) LANETH-75 (UNII: QQ4C4Q56ST) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68121-002-01 354.8 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/30/2020 Labeler - PATCOS COSMETICS (INDIA) PRIVATE LIMITED (916169451) Establishment Name Address ID/FEI Business Operations PATCOS COSMETICS (INDIA) PRIVATE LIMITED 675973979 manufacture(68121-002)