Label: DERMACINRX PENETRAL CREAM- capsaicin cream
- NDC Code(s): 59088-310-16
- Packager: PureTek Corporation
- 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.
Updated February 6, 2019
If you are a consumer or patient please visit this version.
- Active ingredient
For external use only
- This is not a face cream. Do not apply to the face.
- Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
- Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
- Do not bandage tightly.
- Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation.
- Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.
When using this product
do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.
Discontinue use and consult a doctor if
condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using product immediately and get medical attention if experiencing burning, pain, swelling, or blistering of the skin. Rare cases of severe burning or blistering have been reported.
If pregnant, breast-feeding, or any medical conditions exist, ask a health professional before use.
- Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock.
- Before using on children under 18 years of age, consult a physician.
- Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.
- Gently massage into the skin until fully absorbed.
- Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
- Other information
Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Ethylhexylglycerin, Euterpe Oleracea (Acai) Fruit Oil, Glycerin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Lauryl Laurate, Linum Usitatissimum (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine.
- Questions or comments?
- DermacinRx ® Penetral™ Cream (8 fl oz bottle label)
INGREDIENTS AND APPEARANCE
DERMACINRX PENETRAL CREAM
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-310 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ALCOHOL (UNII: 3K9958V90M) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH) LAURYL LAURATE (UNII: GPW77G0937) TROLAMINE (UNII: 9O3K93S3TK) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) FLAX SEED (UNII: 4110YT348C) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) PHENOXYETHANOL (UNII: HIE492ZZ3T) PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X) ROSEMARY OIL (UNII: 8LGU7VM393) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-310-16 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/09/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/09/2015 Labeler - PureTek Corporation (785961046) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 manufacture(59088-310)