OTC Medication Information: Kendra SKIN PROTECTION and PAIN RELIEF FOR HAIR REMOVAL

KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL- lanolin, petrolatum and lidocaine
Natureplex, LLC

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.

A&D OINTMENT

Drug Facts

Active ingredients Purpose
Lanolin 15.5% Skin Protectant
Petrolatum 53.4% Skin protectant

Use

  • temporarily protects and helps relieve minor skin irritation due to tattooing, piercing, and hair removal

Warnings

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately: 1-800-222-1222.

Directions

  • After procedure, apply A&D Skin Protectant as needed to affected skin.

Other information

  • see bottom of carton for lot number and expiration date
  • store at 15 to 30°C (59 to 86°F)
  • do not use if carton is damaged or open
  • do not use if seal on tube is punctured or missing

Inactive ingredients

beeswax, cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax

Questions or Comments?

1-866-323-0107 or www.kendracollection.com

4% LIDOCAINE

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Pain Relieving Cream

Use

  • for temporary relief of pain associated with minor skin irritations due to tattooing, piercing, and hair removal

Warnings

For external use only

Avoid contact with the eyes

Do Not Use

  • if you are allergic to any ingredient in lidocaine cream or to similar medicines (e.g., local anesthetics such as benzocaine)
  • in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use

  • if you have had an allergic reaction (e.g., rash, hives, dizziness) to any anesthetic medicine

Stop use and ask a doctor if

  • you develop a persistent rash
  • conditions worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately: 1-800-222-1222.

Directions

  • For adult use only.
  • Before procedure, apply a small amount of pain relieving cream to affected area, and allow to dry. Application may be repeated up to 4 times daily.

Other information

  • see bottom of carton for lot number and expiration date
  • store at 15 to 30°C (59 to 86°F)
  • do not use if carton is damaged or open
  • do not use if seal on tube is punctured or missing

Inactive ingredients

aloe barbadensis leaf juice, benzophenone-4, cetyl alcohol, dimethyl sulfoxide, jeecide cap-5, L-arginine, purified water, simmondsia chinesis (jojoba) seed oil, sodium polyacrylate, stearic acid, tea tree oil

Questions or Comments?

1-866-323-0107 or www.kendracollection.com

This product
is manufactured
and distributed
by Natureplex™.

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC# 67234-048-01

KENDRA

PAIN RELIEF & SKIN PROTECTANT

A&D OINTMENT SKIN PROTECTANT
1 TUBE NET WT. 1.75 Oz. (49.6g)

LIDOCAINE 4% PAIN RELIEVING CREAM
1 TUBE NET WT. 1.75 Oz. (49.6g)

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL
lanolin, petrolatum and lidocaine kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-048
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67234-048-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 28 g
Part 2 1 TUBE 28 g
Part 1 of 2
A AND D
lanolin and petrolatum ointment, augmented
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lanolin (Lanolin) Lanolin 155 mg in 1 g
Petrolatum (Petrolatum) Petrolatum 534 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX
COD LIVER OIL
LIGHT MINERAL OIL
MICROCRYSTALLINE WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/04/2003
Part 2 of 2
LIDOCAINE PAIN RELIEVING
lidocaine cream
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine (Lidocaine) Lidocaine 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
SULISOBENZONE
CETYL ALCOHOL
DIMETHYL SULFOXIDE
CAPRYLYL GLYCOL
ARGININE
WATER
JOJOBA OIL
SODIUM POLYACRYLATE (2500000 MW)
STEARIC ACID
TEA TREE OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/25/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/04/2003
Labeler — Natureplex, LLC (062808196)
Establishment
Name Address ID/FEI Operations
Natureplex LLC 062808196 MANUFACTURE (67234-048)

Revised: 10/2017 Natureplex, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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