LIDOCAINE- lidocaine 4% cream AvKARE, Inc. 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. ------Lidocaine 4% Cream

Active Ingredient: Lidocaine 4% w/w

Purpose Topical anesthetic

Uses temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites

WARNINGS For external use only.

When using this product do not use in or near the eyes do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if Allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily. Children under 2 years of age: Consult a doctor.

Other Information Store at USP controlled room temperature 20-25 degC (68-77 deg.F). Inactive ingredients Ceteareth-6, ceteareth-25, cetyl alcohol, methylparaben, paraffin, propylene glycol, propylparaben, purified water, stearyl alcohol, and xanthan gum. NDC 42291-399-30 Lidocaine 4% Cream Topical Anesthetic Cream Net Wt. 30 gm Drug Facts Active ingredient Purpose Lidocaine 4% w/w ...... Topical anesthetic Uses Temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor burns minor skin irritations insect bites Warnings For external use only. When using this product do not use in or near the eyes do not use in large quantities, particularly over raw surfaces or blistered ares Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away Directions Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily. Children under 2 years of age: Consult a physician Other Information Store at USP controlled room temperature 20°-25°C (68° - 77°F) Inactive Ingredients Ceteareth-6, ceteareth-25, cetyl alcohol, methylparaben, paraffin, propylene glycol, propylparaben, purified water, stearyl alcohol, xanthan gum. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 AV 03/18 Rev: 03/18 LIDOCAINE lidocaine 4 % cream

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:4229 1-39 9 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7) LIDOCAINE 4 g in 10 0 g

Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9 O0 E3H2ZE) XANTHAN GUM (UNII: TTV12P4NEE) PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) WATER (UNII: 0 59 QF0 KO0 R) CETEARETH-2 5 (UNII: 8 FA9 3U5T6 7) PRO PYLPARABEN (UNII: Z8 IX2SC1OH) CETEARETH-6 (UNII: 2RJS3559 D3) CETYL ALCO HO L (UNII: 9 36 JST6 JCN) METHYLPARABEN (UNII: A2I8 C7HI9 T) STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:4229 1-39 9 -30 1 in 1 CARTON 0 7/10 /20 18 1 30 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 0 7/10 /20 18

Labeler - AvKARE, Inc. (796560394)

Revised: 1/2020 AvKARE, Inc.